EMPOWER Clinical Trial: Vagal Blocking for Obesity Control (EMPOWER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00521079|
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : February 20, 2017
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Therapy ON Device: Therapy OFF||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||EMPOWER Clinical Trial: Vagal Blocking for Obesity Control|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||May 2018|
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
Device: Therapy ON
Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)
Other Name: Maestro System
Sham Comparator: Placebo
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
Device: Therapy OFF
Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)
Other Name: Maestro System
- Percentage of Excess Weight Loss (EWL) With the Maestro System [ Time Frame: 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). [ Time Frame: 1 Year ]To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
- Percentage of Participants Achieving 25% Excess Weight Loss (%EWL) [ Time Frame: Baseline and 1 Year ]To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521079
|United States, Arizona|
|HonorHealth (formerly Scottsdale Bariatric Center)|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|La Jolla, California, United States, 92037|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Florida|
|Cleveland Clinic - Florida|
|Weston, Florida, United States, 33331|
|United States, Maryland|
|Baltimore, Maryland, United States, 21224|
|United States, Massachusetts|
|Tufts New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cleveland Clinic - Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239-3098|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Australia, New South Wales|
|Institute of Weight Control|
|Sydney, New South Wales, Australia, 2153|
|Australia, South Australia|
|Adelaide Bariatric Center - Flinders Private Hospital|
|Bedford Park, South Australia, Australia, 5042|
|Principal Investigator:||Charles J Billington, MD||VA Medical Center, Minneapolis, MN / University of Minnesota|
|Principal Investigator:||Michael Sarr, MD||Mayo Clinic|