<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/NCT03776188</url>
  </required_header>
  <id_info>
    <org_study_id>ES Registry 2-682-101</org_study_id>
    <nct_id>NCT03776188</nct_id>
  </id_info>
  <brief_title>Endoscopic Suturing (ES) Registry</brief_title>
  <official_title>Prospective Registry for Trans-Orifice Endoscopic Suturing Applications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Gastroenterological Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Apollo Endosurgery, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>American Gastroenterological Association</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine patient outcomes (survival, additional endoscopic or surgical procedures) with&#xD;
      an endoscopic suturing technique at predetermined intervals compared to historical controls&#xD;
      when applicable.&#xD;
&#xD;
      To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy&#xD;
      for revision of bariatric procedures as well as study the safety, efficacy, and durability of&#xD;
      preventative fixation of GI endoprosthetics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine patient outcomes (survival, morbidity including hospitalization, additional&#xD;
      re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing&#xD;
      at predetermined intervals from the last endoscopic suturing procedure or at failure of the&#xD;
      endoscopic suturing with conversion to another intervention such as surgery and compared to&#xD;
      historical controls when applicable.&#xD;
&#xD;
      To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation&#xD;
      of stents and bariatric revision.&#xD;
&#xD;
      To collect data on the common use endoscopic suturing therapy in other indications.&#xD;
&#xD;
      This prospective clinical study is a real-world registry and not a randomized controlled&#xD;
      trial. Given the conditions commonly treated with endoscopic suturing and the potential lack&#xD;
      of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all&#xD;
      centers, randomization of participants is not possible nor ethical. In addition, there are&#xD;
      clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or&#xD;
      endoprosthetics may be appropriate and open and laparoscopic surgical approaches&#xD;
      inappropriate from an ethical viewpoint. Given the multitude of currently available minimally&#xD;
      invasive approaches to repair, it would be unethical to expose and randomize patients who are&#xD;
      suitable for more minimally invasive approaches to a more invasive and inherently more morbid&#xD;
      approach.&#xD;
&#xD;
      This outcomes study is external to the subject receiving the medical device treatment.&#xD;
      Subjects will receive the medical device treatment regardless of study participation and the&#xD;
      surgery is not part of this research. Subjects will be consented prior to their procedure, to&#xD;
      obtain basic follow-up information. If the subject provides informed consent to participate&#xD;
      in the registry, then site staff will follow the participant's clinical data for the period&#xD;
      of the registry. Site staff may also contact the subject(s) during their standard clinic&#xD;
      visit or via the telephone and obtain information on: overall health, specific events related&#xD;
      to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.&#xD;
&#xD;
      The clinical data will be collected during usual procedure follow-ups. This will include&#xD;
      recording patient demographics, medications, testing results, comorbidities, body mass index,&#xD;
      and reason for clinical care visit. If during the follow-up period, the subject undergoes&#xD;
      additional clinically indicated procedures or hospitalizations for procedure related&#xD;
      indications then the site will submit this information to the registry.&#xD;
&#xD;
      All procedures and device use will be performed as clinically indicated and as directed by&#xD;
      the treating physician. All information requested as part of this registry will be obtained&#xD;
      from clinical data obtained as part of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Dislocation of Stent - distance</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Change in the position measured using distance (centimeters).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dislocation of Stent - location</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migration Rate of Stent - placement</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Distal from placement over time (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migration Rate of Stent - replaced</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Stent replaced or re-structured over time (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migration Rate of Stent - sutures</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Number of intact Sutures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migration Rate of Stent - removal</measure>
    <time_frame>Change at 2 weeks, 30 days, 3 months</time_frame>
    <description>Days to removal and replacement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Excess Weight Loss</measure>
    <time_frame>Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months</time_frame>
    <description>Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Weight Loss</measure>
    <time_frame>Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months</time_frame>
    <description>Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>no groups - observational study</arm_group_label>
    <description>no groups - observational study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with a condition that can be treated with trans-orifice endoscopic surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Selected to undergo trans-orifice suturing prior to study enrollment&#xD;
&#xD;
          2. Age 18+ years&#xD;
&#xD;
          3. Patient ASA classification I, II, III, including emergency cases&#xD;
&#xD;
          4. Patient willing to provide informed consent, cooperate with post-operative&#xD;
             recommendations and follow-up assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not meet the clinical criteria for trans-orifice suturing&#xD;
&#xD;
          2. Under age 18 years&#xD;
&#xD;
          3. ASA classification IV&#xD;
&#xD;
          4. Unable to provide informed consent&#xD;
&#xD;
          5. Unable to participate in follow-up assessments&#xD;
&#xD;
          6. Uncorrectable coagulopathy at the time of endoscopic suturing&#xD;
&#xD;
          7. Any terminal disease that limits patient's survival to less than one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Maranki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State Milton S. Hershey School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borland Grover Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Medical Institution</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Dallas Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopic Suturing</keyword>
  <keyword>Bariatric Revision</keyword>
  <keyword>Stent Fixation</keyword>
  <keyword>Bariatric Surgery</keyword>
  <!-- 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/NCT03776188
org study id: ES Registry 2-682-101
nct id: NCT03776188
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with
      an endoscopic suturing technique at predetermined intervals compared to historical controls
      when applicable.

      To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy
      for revision of bariatric procedures as well as study the safety, efficacy, and durability of
      preventative fixation of GI endoprosthetics.
To determine patient outcomes (survival, morbidity including hospitalization, additional
      re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing
      at predetermined intervals from the last endoscopic suturing procedure or at failure of the
      endoscopic suturing with conversion to another intervention such as surgery and compared to
      historical controls when applicable.

      To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation
      of stents and bariatric revision.

      To collect data on the common use endoscopic suturing therapy in other indications.

      This prospective clinical study is a real-world registry and not a randomized controlled
      trial. Given the conditions commonly treated with endoscopic suturing and the potential lack
      of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all
      centers, randomization of participants is not possible nor ethical. In addition, there are
      clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or
      endoprosthetics may be appropriate and open and laparoscopic surgical approaches
      inappropriate from an ethical viewpoint. Given the multitude of currently available minimally
      invasive approaches to repair, it would be unethical to expose and randomize patients who are
      suitable for more minimally invasive approaches to a more invasive and inherently more morbid
      approach.

      This outcomes study is external to the subject receiving the medical device treatment.
      Subjects will receive the medical device treatment regardless of study participation and the
      surgery is not part of this research. Subjects will be consented prior to their procedure, to
      obtain basic follow-up information. If the subject provides informed consent to participate
      in the registry, then site staff will follow the participant's clinical data for the period
      of the registry. Site staff may also contact the subject(s) during their standard clinic
      visit or via the telephone and obtain information on: overall health, specific events related
      to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.

      The clinical data will be collected during usual procedure follow-ups. This will include
      recording patient demographics, medications, testing results, comorbidities, body mass index,
      and reason for clinical care visit. If during the follow-up period, the subject undergoes
      additional clinically indicated procedures or hospitalizations for procedure related
      indications then the site will submit this information to the registry.

      All procedures and device use will be performed as clinically indicated and as directed by
      the treating physician. All information requested as part of this registry will be obtained
      from clinical data obtained as part of study.
observational model: Cohort
time perspective: Prospective
measure: Dislocation of Stent - distance
time frame: Change at 2 weeks, 30 days, 3 months
description: Change in the position measured using distance (centimeters).
measure: Dislocation of Stent - location
time frame: Change at 2 weeks, 30 days, 3 months
description: Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
measure: Migration Rate of Stent - placement
time frame: Change at 2 weeks, 30 days, 3 months
description: Distal from placement over time (yes or no)
measure: Migration Rate of Stent - replaced
time frame: Change at 2 weeks, 30 days, 3 months
description: Stent replaced or re-structured over time (yes or no)
measure: Migration Rate of Stent - sutures
time frame: Change at 2 weeks, 30 days, 3 months
description: Number of intact Sutures
measure: Migration Rate of Stent - removal
time frame: Change at 2 weeks, 30 days, 3 months
description: Days to removal and replacement
measure: Excess Weight Loss
time frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
description: Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
measure: Total Weight Loss
time frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
description: Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
arm group label: no groups - observational study
description: no groups - observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jennifer Maranki, MD
role: Principal Investigator
affiliation: Penn State Milton S. Hershey School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor