EMPOWER Clinical Trial: Vagal Blocking for Obesity Control (EMPOWER)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||EMPOWER Clinical Trial: Vagal Blocking for Obesity Control|
- 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.
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|St. 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|