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

• Conditions: Obesity
• Interventions: Device: Reshape Integrated Dual Balloon

• Registration Number: NCT02927665
• Lead Sponsor: ReShape Lifesciences

Brief Summary

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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Subjects	Reshape Integrated Dual Balloon	Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Digestive Health Specialists of the Southeast; 🇺🇸 Dothan, Alabama, United States

Barrington Surgeons; 🇺🇸 Barrington, Illinois, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

New York Bariatric Group; 🇺🇸 Roslyn Heights, New York, United States

JourneyLite Physicians; 🇺🇸 Cincinnati, Ohio, United States

Gastrointestinal Associates, P.C.; 🇺🇸 Knoxville, Tennessee, United States

Salem General Surgery; 🇺🇸 Salem, Ohio, United States

Sage Bariatric Institute; 🇺🇸 San Antonio, Texas, United States

Eviva; 🇺🇸 Shoreline, Washington, United States

Christiana Institute of Advanced Surgery; 🇺🇸 Newark, Delaware, United States

The Gastro Clinic; 🇺🇸 Lafayette, Louisiana, United States

Surgical Specialist of Louisiana; 🇺🇸 Metairie, Louisiana, United States

North Jersey Laparoscopic Associates; 🇺🇸 Teaneck, New Jersey, United States

MidSouth Bariatrics; 🇺🇸 Memphis, Tennessee, United States