EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
vBloc	Therapy ON	Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
Placebo	Therapy OFF	Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).

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.

Locations (15): Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
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
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
Cleveland Clinic - Ohio
🇺🇸
Cleveland, Ohio, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Institute of Weight Control
🇦🇺
Sydney, New South Wales, Australia
Adelaide Bariatric Center - Flinders Private Hospital
🇦🇺
Bedford Park, South Australia, Australia
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States