<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04419779</url>
  </required_header>
  <id_info>
    <org_study_id>C-00044</org_study_id>
    <nct_id>NCT04419779</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy</brief_title>
  <acronym>REVITALIZE 1</acronym>
  <official_title>A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fractyl Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fractyl Laboratories, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Revita® system is being investigated to assess the efficacy of DMR versus Sham on&#xD;
      improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2&#xD;
      Diabetes who are inadequately controlled with insulin therapy. The purpose of this study is&#xD;
      to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System&#xD;
      compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol&#xD;
      till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over&#xD;
      to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2021</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidences and event rates of hypoglycemic events - Primary Outcome 1</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>HbA1c ≤7% without an increase in number of ADAs from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidences and event rates of hypoglycemic events - Primary Outcome 2</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>HbA1c reduction from baseline of ≥1% without an increase in number of ADAs from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidences and event rates of hypoglycemic events - Primary Outcome 3</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>HbA1c reduction from baseline of ≥0.5% without an increase in number of ADAs from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidences and event rates of hypoglycemic events - Primary Outcome 4</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Any HbA1c reduction from baseline without an increase in number of ADAs from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidences and event rates of hypoglycemic events - Primary Outcome 5</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Change in number of prescribed ADAs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Duodenal Mucosal Resurfacing (DMR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with type 2 diabetes on insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duodenal Mucosal Resurfacing Sham (Sham)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes on insulin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duodenal Mucosal Resurfacing (DMR)</intervention_name>
    <description>The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.</description>
    <arm_group_label>Duodenal Mucosal Resurfacing (DMR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duodenal Mucosal Resurfacing (Sham)</intervention_name>
    <description>The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.</description>
    <arm_group_label>Duodenal Mucosal Resurfacing Sham (Sham)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male, and non-pregnant, non-lactating females&#xD;
&#xD;
          2. Age between 21 and 70 years (both inclusive)&#xD;
&#xD;
          3. Subjects with type 2 diabetes on stable doses of 20-100 units (both inclusive) of&#xD;
             total daily insulin dose of basal insulin or basal insulin combined with short-acting&#xD;
             insulin and up to 3 permitted non-insulin antidiabetic agents (ADAs). Permitted&#xD;
             non-insulin ADAs include:&#xD;
&#xD;
               -  Metformin,&#xD;
&#xD;
               -  Glucagon-like peptide-1 receptor agonist (GLP-1 RA) including dual peptide&#xD;
                  agonists and related molecules (e.g., glucose-dependent insulinotropic&#xD;
                  polypeptide (GIP)/GLP-1 RA),&#xD;
&#xD;
               -  Dipeptidyl peptidase 4 inhibitor (DPP-4i),&#xD;
&#xD;
               -  Thiazolidinediones (TZD),&#xD;
&#xD;
               -  Sodium-glucose cotransporter 2 inhibitors (SGLT2i),&#xD;
&#xD;
               -  Sulfonylureas (SU),&#xD;
&#xD;
               -  Meglitinides&#xD;
&#xD;
          4. Glycosylated hemoglobin A1c (HbA1c) of 7.5-10% (both inclusive) confirmed at the end&#xD;
             of at least a 3-week stable run-in period&#xD;
&#xD;
          5. Body mass index (BMI) &gt; 24 to ≤ 40 kg/m^2&#xD;
&#xD;
          6. Women of childbearing potential (WOCBP) should have a negative urine beta human&#xD;
             chorionic gonadotrophin (hCG) pregnancy test and must agree to use two established&#xD;
             contraceptive methods throughout the study duration.&#xD;
&#xD;
          7. Able to sign an informed consent form and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. FPG &gt;270 mg/dL on Visit 1 or Visit 2&#xD;
&#xD;
          2. Known case of absolute insulin deficiency as indicated by clinical assessment, a&#xD;
             history of type 1 diabetes, and a fasting plasma C-peptide of &lt;0.6 ng/ml&#xD;
&#xD;
          3. Subjects who are on any other class of antidiabetic drug agents other than permitted&#xD;
             non-insulin baseline ADAs&#xD;
&#xD;
          4. Any drugs or concomitant medications (e.g., psychoactive drugs such as carbamazepine,&#xD;
             phenobarbital, sympathomimetics such as ephedrine, corticosteroids, anabolic steroids,&#xD;
             and male sex hormones such as testosterone) that can interfere with glucose metabolism&#xD;
&#xD;
          5. Recurrent or severe urinary tract or genital mycotic infections or history of&#xD;
             genitourinary infection within 4 weeks prior to informed consent&#xD;
&#xD;
          6. ALT or AST &gt;3 times upper limit normal values&#xD;
&#xD;
          7. Use of an investigational drug within 1 month or 5 half-lives (whichever is longer)&#xD;
             before the screening&#xD;
&#xD;
          8. Diagnosed with type 1 diabetes or with a recent history of ketoacidosis&#xD;
&#xD;
          9. Ketosis-prone T2D&#xD;
&#xD;
         10. History of non-healing diabetic ulcers or amputations&#xD;
&#xD;
         11. History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within&#xD;
             past 6 months of screening&#xD;
&#xD;
         12. In case of 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear&#xD;
             correctable precipitating factor can be identified / clinically significant&#xD;
             hypoglycemia with self-monitored or laboratory plasma glucose level &lt;54 mg/dL (3.0&#xD;
             mmol/L) /severe hypoglycemic episode requiring third party assistance occurring during&#xD;
             run-in period&#xD;
&#xD;
         13. Known intestinal autoimmune disease, including celiac disease, ulcerative colitis,&#xD;
             Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective&#xD;
             tissue disorder, which affects the small intestine&#xD;
&#xD;
         14. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid&#xD;
             stimulating hormone [TSH] value outside the normal range at screening)&#xD;
&#xD;
         15. Known history of thyroid cancer or hyperthyroidism with treatment within the past 12&#xD;
             months or inadequately controlled hyperthyroidism&#xD;
&#xD;
         16. An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D)&#xD;
&#xD;
         17. Known history of a structural or functional disorder of the esophagus, including any&#xD;
             swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal&#xD;
             reflux symptoms, active and uncontrolled gastroesophageal reflux disease (GERD) (grade&#xD;
             3 esophagitis or greater)&#xD;
&#xD;
         18. Known history of a structural or functional disorder of the stomach including gastric&#xD;
             ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or&#xD;
             type II and higher paraoesophageal hernia), cancer, or any other disorder of the&#xD;
             stomach&#xD;
&#xD;
         19. Previous GI surgery that could affect the ability to treat the duodenum such as&#xD;
             subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve or other&#xD;
             similar procedures or conditions&#xD;
&#xD;
         20. Known history of chronic pancreatitis or a recent history of acute pancreatitis within&#xD;
             the past year&#xD;
&#xD;
         21. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured)&#xD;
             or cirrhosis; hepatic decompensation/acute liver disease during the last 6 months; or&#xD;
             alcoholic or autoimmune chronic hepatitis&#xD;
&#xD;
         22. Symptomatic gallstones, symptomatic kidney stones, or acute cholecystitis&#xD;
&#xD;
         23. Clinically active systemic infection&#xD;
&#xD;
         24. Known immunocompromised status including but not limited to individuals who have&#xD;
             undergone organ transplantation, chemotherapy, or radiotherapy within the past 12&#xD;
             months; have clinically significant leukopenia; are positive for the human&#xD;
             immunodeficiency virus (HIV); are on potential immunosuppressants; or individuals&#xD;
             whose immune status makes the subject a poor candidate for clinical trial&#xD;
             participation in the opinion of the Investigator&#xD;
&#xD;
         25. History of active malignancy or partial remission from clinically significant&#xD;
             malignancy within the past 5 years (except basal or squamous cell skin cancer,&#xD;
             carcinoma in situ, those who received curative treatment and are in complete remission&#xD;
             for 5 years, or if the subject is confirmed as cancer free)&#xD;
&#xD;
         26. Known active coagulopathy or current upper gastro-intestinal bleeding conditions such&#xD;
             as ulcers, gastric varices, strictures, or congenital or acquired intestinal&#xD;
             telangiectasia&#xD;
&#xD;
         27. Known cases of anemia, thalassemia, or conditions that affect red blood cell (RBC)&#xD;
             turnover such as a recent blood transfusion within 90 days&#xD;
&#xD;
         28. Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants&#xD;
             such as NOAC) or anti-platelet agents (e.g., thienopyridine) which cannot be&#xD;
             discontinued for 5-7 days or 2 drug half-lives before the procedure&#xD;
&#xD;
         29. Use of systemic glucocorticoids (excluding topical or ophthalmic applications or&#xD;
             inhaled forms) for more than 10 consecutive days within 90 days prior to the screening&#xD;
             visit&#xD;
&#xD;
         30. Use of drugs known to affect GI motility (e.g., metoclopramide)&#xD;
&#xD;
         31. History of moderate to severe chronic kidney disease (CKD) with an estimated&#xD;
             glomerular filtration rate (eGFR) of &lt;45 mL/min/1.73m2 (estimated by Modification of&#xD;
             Diet in Renal Disease [MDRD]), end-stage renal failure, or on dialysis&#xD;
&#xD;
         32. History of myocardial infarction, stroke, TIA, coronary artery intervention, CHF&#xD;
             exacerbation, or a major event requiring hospitalization within the last 6 months&#xD;
             prior to screening&#xD;
&#xD;
         33. History of new or worsening signs or symptoms of coronary heart disease (CHD) within&#xD;
             the last 3 months&#xD;
&#xD;
         34. Known case of severe peripheral vascular disease&#xD;
&#xD;
         35. Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class&#xD;
             II-IV) requiring pharmacologic therapy to control symptoms&#xD;
&#xD;
         36. Clinically significant electrocardiogram (ECG) findings such as new clinically&#xD;
             significant arrhythmia or conduction disturbances that increase risk and require&#xD;
             intervention as determined by the investigator&#xD;
&#xD;
         37. Subjects who are at risk of pancreatitis, particularly those with a recent fasting&#xD;
             triglyceride value of &gt;600 mg/dL within the past 3 months&#xD;
&#xD;
         38. Actively participating in a weight-loss program and currently not in the maintenance&#xD;
             phase&#xD;
&#xD;
         39. General contraindications to deep or conscious sedation, general anesthesia, high risk&#xD;
             as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications&#xD;
             to upper GI endoscopy&#xD;
&#xD;
         40. History of any illicit alcohol or substance abuse&#xD;
&#xD;
         41. Use of weight loss medication such as Meridia, Xenical, over-the-counter weight-loss&#xD;
             medications, or other prescribed medications used specifically for the purpose of&#xD;
             weight loss&#xD;
&#xD;
         42. Use of dietary supplements or herbal preparations that may have unknown effects on&#xD;
             glycemic control or risk of bleeding&#xD;
&#xD;
         43. Participating in another ongoing clinical trial of an investigational drug or device&#xD;
&#xD;
         44. History of non-adherence to treatment in the previous 6 months, as determined by the&#xD;
             investigator based on patient history, HbA1c value, or drug accountability&#xD;
&#xD;
         45. Any other mental or physical condition which, in the opinion of the investigator,&#xD;
             makes the subject a poor candidate for clinical-trial participation&#xD;
&#xD;
         46. Unwilling or unable to perform SMBG, complete the subject glycemia diary, or comply&#xD;
             with study visits and other study procedures as required per protocol&#xD;
&#xD;
         47. Recovered from severe COVID-19 infection (requiring hospitalization) but with&#xD;
             persistent long COVID-19 symptoms (i.e., the individual has not recovered for several&#xD;
             weeks or months since the start of symptoms that were suggestive of COVID-19,&#xD;
             irrespective if the individual is tested or not)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lynn Wilson</last_name>
    <phone>781-208-2564</phone>
    <email>lwilson@fractyl.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelly White</last_name>
    <email>kwhite@fractyl.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85295</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Stanchfield</last_name>
      <email>Stanchfield.Katrina@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Rahul Pannala</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lori Roust</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCLA Health</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>(Anna) Chen Zheng</last_name>
      <phone>310-794-0129</phone>
      <email>Czheng@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Adarsh Thaker</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthrew Freeby</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Swati Toppo</last_name>
      <phone>650-497-4151</phone>
      <email>stoppo@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Paul Kwo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mills Peninsula Health Center</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irina Nayberg</last_name>
      <email>nayberl@sutterhealth.org</email>
    </contact>
    <investigator>
      <last_name>David Klonoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacqueline Prinz</last_name>
      <phone>203-785-5977</phone>
      <email>jacqueline.prinz@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Renata Belfort De Aguiar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Niurka Colina</last_name>
      <phone>305-243-6405</phone>
      <email>Nxc610@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Paul Martin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Unviersity</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Candice Fulkerson</last_name>
      <phone>312-908-9002</phone>
      <email>candice.fulkerson@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Grazia Aleppo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Patrick, RN</last_name>
      <phone>317-278-0692</phone>
      <email>vpatrick@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Raj Vuppalanchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Karen James</last_name>
      <phone>502-852-2902</phone>
      <email>karen.james@louisville.edu</email>
    </contact>
    <investigator>
      <last_name>Prakash Mokshagundam</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tulane University</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elvia Haynes</last_name>
      <phone>504-988-4651</phone>
      <email>ehaynes@tulane.edu</email>
    </contact>
    <investigator>
      <last_name>Vivian Fonseca, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katherine Nicastro</last_name>
      <email>knicastro@bwh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Vanita Aroda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beth Israel</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Shea</last_name>
      <phone>617-632-1129</phone>
      <email>jmshea@bidmc.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Michelle Lai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam Neidert</last_name>
      <phone>734-615-0539</phone>
      <email>aneidert@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Elif Oral</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arb Teresa</last_name>
      <phone>314-747-1217</phone>
      <email>arbt@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Julie Silverstein</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracy Ostler</last_name>
      <phone>603-653-9033</phone>
      <email>Tracy.L.Ostler@hitchcock.org</email>
    </contact>
    <investigator>
      <last_name>Sushela Chaidarun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Joseph Medical Center</name>
      <address>
        <city>Paterson</city>
        <state>New Jersey</state>
        <zip>07501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>NYU Langone Gastroenterology Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gigi Ghiasian</last_name>
      <phone>201-410-6849</phone>
      <email>Ghoncheh.Ghiasian@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Akankasha Goyal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachelle Jacoby</last_name>
      <email>rachelle.jacoby@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Reshmi Srinath</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>April Wittmann</last_name>
      <phone>919-668-1220</phone>
      <email>april.hawkins@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Jennifer Rowell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Schnieder</last_name>
      <phone>216-444-1122</phone>
      <email>SCHNEIES@ccf.org</email>
    </contact>
    <investigator>
      <last_name>John Vargo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katherine Yerkes</last_name>
      <email>KATHERINE.YERKES@PENNMEDICINE.UPENN.EDU</email>
    </contact>
    <investigator>
      <last_name>Anastasia Amaro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Mercado</last_name>
      <phone>713-798-3606</phone>
      <email>Michael.Mercado@bcm.edu</email>
    </contact>
    <investigator>
      <last_name>Dimpi Desai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Collen</last_name>
      <phone>804-628-4376</phone>
      <email>rebecca.collen@vcuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Arun Sanyal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Nguyen</last_name>
    </contact>
    <investigator>
      <last_name>Arthi Thiramulai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cami Handlan</last_name>
      <phone>304-293-6360</phone>
      <email>cami.handlan@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Adnan Haider</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Bruxelles Hopital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitri Oger</last_name>
      <phone>+32 (0) 2555 5828</phone>
      <email>Dimitri.Oger@erasme.ulb.ac.be</email>
    </contact>
    <investigator>
      <last_name>Miriam Cnop</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bichat-Claude Bernard Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marilyne Hallot-Feron</last_name>
      <phone>+33 (0)140258880</phone>
      <email>marilyne.feron@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Ronan Roussel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University College Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Camilo Menezes</last_name>
      <email>camilo.menezes@ucd.ie</email>
    </contact>
    <investigator>
      <last_name>Carel le Roux</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Italy Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Caprodossi</last_name>
      <phone>+39 06 30155323</phone>
      <email>anna.caprodossi@policlinicogemelli.it</email>
    </contact>
    <investigator>
      <last_name>Geltrude Mingrone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universiteit Van Amsterdam Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjon Barlag</last_name>
      <phone>+31-20-5668713</phone>
      <email>m.j.barlag@amsterdamumc.nl</email>
    </contact>
    <investigator>
      <last_name>Jacques Bergman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathrin Husi</last_name>
      <phone>+41316325933</phone>
      <email>kathrin.husi@insel.ch</email>
    </contact>
    <investigator>
      <last_name>Reiner Wiest</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>CH-8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabler Verena</last_name>
      <phone>+41 43 253 88 40</phone>
      <email>verena.gabler@usz.ch</email>
    </contact>
    <investigator>
      <last_name>Felix Beuschlein</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sim Ratcliff</last_name>
      <email>simbisai.ratcliff@nhs.net</email>
    </contact>
    <investigator>
      <last_name>David Hopkins</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Glucose Metabolism Disorders</keyword>
  <keyword>Metabolic Diseases</keyword>
  <keyword>Endocrine System Diseases</keyword>
  <keyword>Revita System</keyword>
  <keyword>Duodenal Mucosal Resurfacing</keyword>
  <keyword>Insulin-Dependent Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04419779
org study id: C-00044
nct id: NCT04419779
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on
      improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2
      Diabetes who are inadequately controlled with insulin therapy. The purpose of this study is
      to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System
      compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol
      till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over
      to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidences and event rates of hypoglycemic events - Primary Outcome 1
time frame: Baseline to Week 24
description: HbA1c ≤7% without an increase in number of ADAs from baseline
measure: Incidences and event rates of hypoglycemic events - Primary Outcome 2
time frame: Baseline to Week 24
description: HbA1c reduction from baseline of ≥1% without an increase in number of ADAs from baseline
measure: Incidences and event rates of hypoglycemic events - Primary Outcome 3
time frame: Baseline to Week 24
description: HbA1c reduction from baseline of ≥0.5% without an increase in number of ADAs from baseline
measure: Incidences and event rates of hypoglycemic events - Primary Outcome 4
time frame: Baseline to Week 24
description: Any HbA1c reduction from baseline without an increase in number of ADAs from baseline
measure: Incidences and event rates of hypoglycemic events - Primary Outcome 5
time frame: Baseline to Week 24
description: Change in number of prescribed ADAs
arm group label: Duodenal Mucosal Resurfacing (DMR)
arm group type: Active Comparator
description: Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with type 2 diabetes on insulin.
arm group label: Duodenal Mucosal Resurfacing Sham (Sham)
arm group type: Sham Comparator
description: Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes on insulin.
intervention type: Device
intervention name: Duodenal Mucosal Resurfacing (DMR)
description: The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
arm group label: Duodenal Mucosal Resurfacing (DMR)
intervention type: Device
intervention name: Duodenal Mucosal Resurfacing (Sham)
description: The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
arm group label: Duodenal Mucosal Resurfacing Sham (Sham)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lynn Wilson
phone: 781-208-2564
email: lwilson@fractyl.com
last name: Kelly White
email: kwhite@fractyl.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Belgium
country: France
country: Ireland
country: Italy
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
country: United States
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No