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A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects | Clinical Trials | Clareo Health

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

NCT02927665•ReShape Lifesciences

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (14)

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Christiana Institute of Advanced Surgery

Newark, Delaware, United States

Barrington Surgeons

Barrington, Illinois, United States

The Gastro Clinic

Lafayette, Louisiana, United States

Surgical Specialist of Louisiana

Metairie, Louisiana, United States

Washington University

St Louis, Missouri, United States

North Jersey Laparoscopic Associates

Teaneck, New Jersey, United States

New York Bariatric Group

Roslyn Heights, New York, United States

JourneyLite Physicians

Cincinnati, Ohio, United States

Salem General Surgery

Salem, Ohio, United States

Key Dates

Start Date

September 1, 2016

Primary Completion Date

November 1, 2019

Completion Date

December 1, 2019

Last Updated

March 29, 2019

Enrollment

186

ACTUAL participants

Conditions

Obesity

Interventions

Reshape Integrated Dual Balloon

DEVICE

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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