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A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duoâ„¢ Intragastric Balloon System in Obese Subjects

NCT01673698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2015-12-07

Study results available
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Summary

The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.

Conditions

Interventions

DEVICE

ReShape Duo balloon

OTHER

Diet counseling

OTHER

Exercise counseling

Sponsors & Collaborators

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • John Lehmann, MD, MPH · Lehmann Consulting

  • Jaime Ponce, MD · Hamilton Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-04-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01673698 on ClinicalTrials.gov