A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
ReShapePAS
1 other identifier
observational
186
1 country
14
Brief Summary
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 29, 2019
March 1, 2019
3.2 years
October 5, 2016
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of ReShape Dual Balloon Treatment
Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
24 weeks
Study Arms (1)
Study Subjects
Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting
Interventions
Eligibility Criteria
Obese patients with a body mass index (BMI) of 30-40 and one or more obesity-related comorbid conditions, who have failed weight reduction with diet and exercise alone
You may qualify if:
- Ages 22 and older
- Baseline BMI 30 - 40
- Failed weight reduction with diet and exercise alone
- One or more obesity-related comorbid conditions
- If female of child bearing potential, willing to avoid pregnancy during course of treatment
You may not qualify if:
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
- Prior open or laparoscopic bariatric surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- 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.
- A gastric mass.
- A hiatal hernia \> 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
- 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.
- Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
- Severe coagulopathy
- Hepatic insufficiency or cirrhosis
- 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.
- Alcoholism or drug addiction.
- Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Christiana Institute of Advanced Surgery
Newark, Delaware, 19713, United States
Barrington Surgeons
Barrington, Illinois, 60010, United States
The Gastro Clinic
Lafayette, Louisiana, 70503, United States
Surgical Specialist of Louisiana
Metairie, Louisiana, 70001, United States
Washington University
St Louis, Missouri, 63110, United States
North Jersey Laparoscopic Associates
Teaneck, New Jersey, 07666, United States
New York Bariatric Group
Roslyn Heights, New York, 11577, United States
JourneyLite Physicians
Cincinnati, Ohio, 45241, United States
Salem General Surgery
Salem, Ohio, 44460, United States
Gastrointestinal Associates, P.C.
Knoxville, Tennessee, 37909, United States
MidSouth Bariatrics
Memphis, Tennessee, 38120, United States
Sage Bariatric Institute
San Antonio, Texas, 78240, United States
Eviva
Shoreline, Washington, 98155, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Shikora
ReShape Lifesciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 7, 2016
Study Start
September 1, 2016
Primary Completion
November 1, 2019
Study Completion
December 1, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share