EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
This trial is active, not recruiting.
|Treatment||active, implantable, intra-abdominal vagal blocking medical device|
|Start date||August 2007|
|End date||June 2013|
|Trial size||300 participants|
|Trial identifier||NCT00521079, D00343-000|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||Scottsdale Bariatric Center||no longer recruiting|
|La Jolla, CA||Scripps Clinic||no longer recruiting|
|Orange, CA||University of California, Irvine Medical Center||no longer recruiting|
|Stanford, CA||Stanford University Medical Center||no longer recruiting|
|Weston, FL||Cleveland Clinic - Florida||no longer recruiting|
|Baltimore, MD||Johns Hopkins||no longer recruiting|
|Boston, MA||Tufts New England Medical Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Cleveland, OH||Cleveland Clinic - Ohio||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Richmond, VA||Virginia Commonwealth University||no longer recruiting|
|Sydney, Australia||Institute of Weight Control||no longer recruiting|
|Bedford Park, Australia||Adelaide Bariatric Center - Flinders Private Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
To demonstrate a significantly greater percentage of excess weight loss with the Maestro System which provides VBLOC therapy.
time frame: 1 Year
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
time frame: 1 Year
To demonstrate a significant difference between treatment groups in the proportion of subjects realizing at least a 25% excess weight loss from implant.
time frame: 1 Year
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Informed consent. - Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more severe obesity related co-morbid condition. - Females or males - 18-65 years of age inclusive. - Type 2 diabetes mellitus subjects that are well-controlled (at selected centers, limited to approximately 26 subjects). - Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months. - Ability to complete all study visits and procedures. Exclusion Criteria: - Concurrent chronic pancreatic disease. - History of Crohn's disease and/or ulcerative colitis. - History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery. - History of pulmonary embolism or blood coagulation disorders. - Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant. - Current portal hypertension and/or esophageal varices. - Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery. - Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial. - Smoking cessation within the prior six months. - Known genetic cause of obesity. - Overall sustained reduction of more than 10% of body weight in the previous 12 months. - Pre-operative diet with intent to lose weight prior to surgery.
|Official title||EMPOWER Clinical Trial: Vagal Blocking for Obesity Control|
|Principal investigator||Charles J Billington, MD|
|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 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.|
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