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EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

NCT00521079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2018-08-24

Study results available
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Summary

This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.

Conditions

Interventions

DEVICE

Therapy ON

Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)

DEVICE

Therapy OFF

Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)

Sponsors & Collaborators

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • Charles J Billington, MD · VA Medical Center, Minneapolis, MN / University of Minnesota

  • Michael Sarr, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-10-31
Completion
2018-05-31

Countries

  • United States
  • Australia

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 NCT00521079 on ClinicalTrials.gov