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

Status unconfirmed

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT02927665

Run by

ReShape Lifesciences

People needed

186

Starts

2016-09-01

Expected to finish

2019-12-01

Last updated by the study team

2019-03-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
• 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.
• Patients who are pregnant or breast-feeding.
• Significant endoscopic abnormalities immediately prior to device insertion.

Where it is running

• 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
• Gastrointestinal Associates, P.C. — Knoxville, Tennessee, United States
• MidSouth Bariatrics — Memphis, Tennessee, United States
• Sage Bariatric Institute — San Antonio, Texas, United States
• Eviva — Shoreline, Washington, United States

Full record on ClinicalTrials.gov

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