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ReShapePAS: A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects

Sponsor
ReShape Lifesciences (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02927665
Collaborator
(none)
186
Enrollment
14
Locations
39
Duration (Months)
13.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.

Condition or Disease Intervention/Treatment Phase
  • Device: Reshape Integrated Dual Balloon

Detailed Description

The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label clinical study intended to collect valid scientific evidence regarding the safety and efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial clinical setting.

Study Design

Study Type:
Observational
Actual Enrollment :
186 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Study Subjects

Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting

Device: Reshape Integrated Dual Balloon
Other Names:
  • Reshape Integrated Dual Balloon System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of ReShape Dual Balloon Treatment [24 weeks]

      Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Ages 22 and older

    2. Baseline BMI 30 - 40

    3. Failed weight reduction with diet and exercise alone

    4. One or more obesity-related comorbid conditions

    5. If female of child bearing potential, willing to avoid pregnancy during course of treatment

    Exclusion Criteria:

    1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions

    2. Prior open or laparoscopic bariatric surgery.

    3. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.

    4. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.

    5. A gastric mass.

    6. A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.

    7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.

    8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device

    9. Severe coagulopathy

    10. Hepatic insufficiency or cirrhosis

    11. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.

    12. Alcoholism or drug addiction.

    13. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.

    14. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.

    15. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.

    16. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.

    17. Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.

    18. Patients who are pregnant or breast-feeding.

    19. Significant endoscopic abnormalities immediately prior to device insertion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Digestive Health Specialists of the Southeast Dothan Alabama United States 36305
    2 Christiana Institute of Advanced Surgery Newark Delaware United States 19713
    3 Barrington Surgeons Barrington Illinois United States 60010
    4 The Gastro Clinic Lafayette Louisiana United States 70503
    5 Surgical Specialist of Louisiana Metairie Louisiana United States 70001
    6 Washington University Saint Louis Missouri United States 63110
    7 North Jersey Laparoscopic Associates Teaneck New Jersey United States 07666
    8 New York Bariatric Group Roslyn Heights New York United States 11577
    9 JourneyLite Physicians Cincinnati Ohio United States 45241
    10 Salem General Surgery Salem Ohio United States 44460
    11 Gastrointestinal Associates, P.C. Knoxville Tennessee United States 37909
    12 MidSouth Bariatrics Memphis Tennessee United States 38120
    13 Sage Bariatric Institute San Antonio Texas United States 78240
    14 Eviva Shoreline Washington United States 98155

    Sponsors and Collaborators

    • ReShape Lifesciences

    Investigators

    • Study Director: Scott Shikora, ReShape Lifesciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ReShape Lifesciences
    ClinicalTrials.gov Identifier:
    NCT02927665
    Other Study ID Numbers:
    • ReShape Post Approval Study
    First Posted:
    Oct 7, 2016
    Last Update Posted:
    Mar 29, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by ReShape Lifesciences
    Weight Loss

    Study Results

    No Results Posted as of Mar 29, 2019