EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT00521079
• Lead Sponsor: ReShape Lifesciences

Brief 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.

Detailed Description

The Maestro System is a neuromodulation system that consists of implantable and external components.

Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.

External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.

All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.

All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-27
• Primary Completion: 2009-10
• Results First Submitted: 2016-08-23
• Results First Submitted QC: 2016-12-28
• Results First Posted: 2017-02-20
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Excess Weight Loss (EWL) With the Maestro System	Baseline and 1 Year	Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Rate of System and Procedure-related Serious Adverse Events (SAEs).	1 Year	To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)	Baseline and 1 Year	To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.

Trial Locations

Locations (15)

HonorHealth (formerly Scottsdale Bariatric Center); 🇺🇸 Scottsdale, Arizona, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Cleveland Clinic - Florida; 🇺🇸 Weston, Florida, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Tufts New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

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