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The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

NCT01061385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-05-13

Study results available
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Summary

The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.

Conditions

Interventions

DEVICE

ReShape Intragastric Balloon

Placement of ReShape Medical Intragastric Balloon for twenty four weeks

OTHER

Control Arm

Behavioral Modification (Diet and exercise counseling) alone

Sponsors & Collaborators

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • Mary Lou Mooney · ReShape Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2011-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061385 on ClinicalTrials.gov