CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 294 enrolled
Drug / intervention
Therapy ON +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00521079
NCT00521079N/ACompleted

EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

ReShape Lifesciences·interventional·Posted Aug 27, 2007·Updated Aug 24, 2018

In Brief

A clinical study evaluating Therapy ON and Therapy OFF for Obesity. Completed, enrolled 294 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesAustralia, United States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2009
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.8 years ago

Interventions

Therapy ONdevice

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

Therapy OFFdevice

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