xml: <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/NCT05984238</url>
    </required_header>
    <id_info>
      <org_study_id>NL83266.000.22</org_study_id>
      <nct_id>NCT05984238</nct_id>
    </id_info>
    <brief_title>A Trial to Evaluate Safety, Feasibility and Efficacy of the ReCET Procedure (EMINENT-2)</brief_title>
    <acronym>EMINENT-2</acronym>
    <official_title>Endoscopic Application of Pulsed Electric Fields Using by the Endogenex Generation 2 ReCET System for Duodenal Mucosal Regeneration for EliMination of INsulin in the treatmENT of Type 2 Diabetes: a Randomized Double-blind Sham Controlled Trial to Evaluate Safety, Feasibility and Efficacy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Endogenex</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed&#xD;
        electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the&#xD;
        Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects&#xD;
        with insulin-dependent type 2 diabetes mellitus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed&#xD;
        electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the&#xD;
        Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects&#xD;
        with insulin-dependent type 2 diabetes mellitus and an adequate beta cell reserve in a&#xD;
        randomized sham-controlled study. The aimed effect is an adequate or improved glucose&#xD;
        regulation without the need for insulin therapy. Secondary effects include improved&#xD;
        cardiovascular, hepatic, and metabolic parameters.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>Crossover Assignment</intervention_model>
      <intervention_model_description>This study is a single-center, double-blind, sham-controlled trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>In this study, both the study team and the study subjects are blinded to the treatment through the 24 week follow-up visit. While the endoscopist is not blinded to individual treatments, he or she is blinded to cohort level data and is not responsible for patient follow-up. At the 24 week visit, the subject and study team are unblinded. The subjects who received the sham treatment undergo ReCET.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]</measure>
      <time_frame>24 weeks</time_frame>
      <description>The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post ReCET procedure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of patients off insulin at 24 weeks [efficacy]</measure>
      <time_frame>24 weeks</time_frame>
      <description>Percentage of patients free of insulin at 24 weeks post ReCET with an HbA1c ≤ 58 mmol/mol compared to sham.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary safety endpoint 1 - hypoglycemic events</measure>
      <time_frame>Through study completion (1 to 1,5 year)</time_frame>
      <description>Number of hypoglycemic events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary safety endpoint 2 - SAEs</measure>
      <time_frame>Through study completion (1 to 1,5 year)</time_frame>
      <description>All SAEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary feasibility endpoint 1 - technical success rate</measure>
      <time_frame>24 weeks (after cross-over)</time_frame>
      <description>Technical success rate, defined as percentage of subjects successfully completed the ReCET procedure (defined as ≥ 3 ablations).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary feasibility endpoint 2 - GLP-1RA tolerability</measure>
      <time_frame>Through study completion (1 to 1,5 year)</time_frame>
      <description>Percentage of subjects adequately using and tolerating GLP-1RA (semaglutide).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary efficay endpoint 1 - HbA1c 48 weeks</measure>
      <time_frame>at 48 weeks</time_frame>
      <description>Protocol driven number of subjects free of insulin at 48 weeks, including an HbA1c ≤ 58 mmol/mol.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>ReCET procedure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive ReCET (Re-Cellularization via Electroporation Therapy), which is performed using the ReCET device.&#xD;
  After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham procedure</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes.&#xD;
  After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ReCET</intervention_name>
      <description>Investigational product.</description>
      <arm_group_label>ReCET procedure</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Semaglutide, 1.0 mg/mL</intervention_name>
      <description>Already registered medicine for type 2 diabetes</description>
      <arm_group_label>ReCET procedure</arm_group_label>
      <arm_group_label>Sham procedure</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham procedure</intervention_name>
      <description>The sham control for the ReCET procedure.</description>
      <arm_group_label>Sham procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed with type 2 diabetes mellitus&#xD;
  &#xD;
            2. 28 - 75 years of age&#xD;
  &#xD;
            3. On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1&#xD;
               month&#xD;
  &#xD;
            4. BMI ≥ 24 and ≤ 42 kg/m2&#xD;
  &#xD;
            5. HbA1c ≤ 64 mmol/mol (8.0%)&#xD;
  &#xD;
            6. Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)&#xD;
  &#xD;
            7. Willing to comply with study requirements and able to understand and comply with&#xD;
               signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis&#xD;
  &#xD;
            2. Current use of multiple daily doses insulin or insulin pump.&#xD;
  &#xD;
            3. Current or within the last 3 months use of a GLP-1 analogue.&#xD;
  &#xD;
            4. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac&#xD;
               disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or&#xD;
               other autoimmune connective tissue disorder&#xD;
  &#xD;
            5. Previous GI surgery that could affect the ability to treat the duodenum such as&#xD;
               subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar&#xD;
               procedures or conditions&#xD;
  &#xD;
            6. History of chronic or acute pancreatitis&#xD;
  &#xD;
            7. Known active hepatitis or active liver disease&#xD;
  &#xD;
            8. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal&#xD;
               inflammatory diseases including Crohn's Disease and Celiac Disease&#xD;
  &#xD;
            9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers,&#xD;
               gastric varices, strictures, congenital or acquired intestinal telangiectasia&#xD;
  &#xD;
           10. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) which cannot&#xD;
               be discontinued for 3-5 days before and 48 hours after the procedure and novel oral&#xD;
               anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot&#xD;
               be discontinued for 48 hours before and 48 hours after the procedure in accordance&#xD;
               with the local protocol&#xD;
  &#xD;
           11. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be&#xD;
               discontinued for 5 days before and 48 hours after the procedure in accordance with the&#xD;
               local protocol. Use of aspirin is allowed.&#xD;
  &#xD;
           12. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment&#xD;
               through 4 weeks post procedure phase&#xD;
  &#xD;
           13. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)&#xD;
  &#xD;
           14. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight&#xD;
               loss medications&#xD;
  &#xD;
           15. Anemia, defined as Hgb &lt; 6.2 mmol/l&#xD;
  &#xD;
           16. Known history of severe permanent cardiac arrhythmia's with clinical symptoms&#xD;
  &#xD;
           17. Significant cardiovascular disease, including known history of valvular disease or&#xD;
               myocardial infarction, heart failure, transient ischemic attack, or stroke within 6&#xD;
               months prior to the screening visit&#xD;
  &#xD;
           18. With any implanted electronic devices or duodenal metallic implants&#xD;
  &#xD;
           19. eGFR or MDRD &lt; 30 ml/min/1.73m^2&#xD;
  &#xD;
           20. Active systemic infection&#xD;
  &#xD;
           21. Active malignancy within the last 5 years&#xD;
  &#xD;
           22. Not potential candidates for surgery or general anesthesia&#xD;
  &#xD;
           23. Active illicit substance abuse or alcoholism&#xD;
  &#xD;
           24. Pregnancy or wish getting pregnant in next year&#xD;
  &#xD;
           25. Participating in another ongoing clinical trial of an investigational drug or device&#xD;
               that can interfere with the current study.&#xD;
  &#xD;
           26. 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;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>28 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacques JG Bergman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Celine BE Busch, MD</last_name>
      <phone>+31621357593</phone>
      <email>c.b.busch@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kim van den Hoek, MD</last_name>
      <phone>+31621357593</phone>
      <email>k.vandenhoek@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amsterdam UMC</name>
        <address>
          <city>Amsterdam</city>
          <state>North-Holland</state>
          <zip>1105 AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Celine BE Busch, MD</last_name>
        <phone>+31621357593</phone>
        <email>diabetes-onderzoek@amsterdamumc.nl</email>
      </contact>
      <investigator>
        <last_name>Jacques JG Bergman, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Celine BE Busch, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <link>
      <url>https://onderzoekdiabetes.nl/</url>
      <description>Website for people that are interested in participating.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Jacques J.G.H.M. Bergman</investigator_full_name>
      <investigator_title>prof. dr.</investigator_title>
    </responsible_party>
    <keyword>Type 2 Diabetes</keyword>
    <keyword>Duodenal ablation</keyword>
    <keyword>Endoscopy</keyword>
    <keyword>Electroporation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
text: 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/NCT05984238
  org study id: NL83266.000.22
  nct id: NCT05984238
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed
        electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the
        Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects
        with insulin-dependent type 2 diabetes mellitus.
  The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed
        electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the
        Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects
        with insulin-dependent type 2 diabetes mellitus and an adequate beta cell reserve in a
        randomized sham-controlled study. The aimed effect is an adequate or improved glucose
        regulation without the need for insulin therapy. Secondary effects include improved
        cardiovascular, hepatic, and metabolic parameters.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This study is a single-center, double-blind, sham-controlled trial.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: In this study, both the study team and the study subjects are blinded to the treatment through the 24 week follow-up visit. While the endoscopist is not blinded to individual treatments, he or she is blinded to cohort level data and is not responsible for patient follow-up. At the 24 week visit, the subject and study team are unblinded. The subjects who received the sham treatment undergo ReCET.
  measure: Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]
  time frame: 24 weeks
  description: The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post ReCET procedure.
  measure: Percentage of patients off insulin at 24 weeks [efficacy]
  time frame: 24 weeks
  description: Percentage of patients free of insulin at 24 weeks post ReCET with an HbA1c ≤ 58 mmol/mol compared to sham.
  measure: Secondary safety endpoint 1 - hypoglycemic events
  time frame: Through study completion (1 to 1,5 year)
  description: Number of hypoglycemic events
  measure: Secondary safety endpoint 2 - SAEs
  time frame: Through study completion (1 to 1,5 year)
  description: All SAEs
  measure: Secondary feasibility endpoint 1 - technical success rate
  time frame: 24 weeks (after cross-over)
  description: Technical success rate, defined as percentage of subjects successfully completed the ReCET procedure (defined as ≥ 3 ablations).
  measure: Secondary feasibility endpoint 2 - GLP-1RA tolerability
  time frame: Through study completion (1 to 1,5 year)
  description: Percentage of subjects adequately using and tolerating GLP-1RA (semaglutide).
  measure: Secondary efficay endpoint 1 - HbA1c 48 weeks
  time frame: at 48 weeks
  description: Protocol driven number of subjects free of insulin at 48 weeks, including an HbA1c ≤ 58 mmol/mol.
  arm group label: ReCET procedure
  arm group type: Active Comparator
  description: Patients receive ReCET (Re-Cellularization via Electroporation Therapy), which is performed using the ReCET device.
  After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started.
  arm group label: Sham procedure
  arm group type: Sham Comparator
  description: Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes.
  After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started
  intervention type: Device
  intervention name: ReCET
  description: Investigational product.
  arm group label: ReCET procedure
  intervention type: Drug
  intervention name: Semaglutide, 1.0 mg/mL
  description: Already registered medicine for type 2 diabetes
  arm group label: ReCET procedure
  arm group label: Sham procedure
  intervention type: Other
  intervention name: Sham procedure
  description: The sham control for the ReCET procedure.
  arm group label: Sham procedure
  criteria: 
  gender: All
  minimum age: 28 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jacques JG Bergman, MD
  role: Principal Investigator
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  last name: Celine BE Busch, MD
  phone: +31621357593
  email: c.b.busch@amsterdamumc.nl
  last name: Kim van den Hoek, MD
  phone: +31621357593
  email: k.vandenhoek@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Netherlands
  url: https://onderzoekdiabetes.nl/
  description: Website for people that are interested in participating.
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Jacques J.G.H.M. Bergman
  investigator title: prof. dr.
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No