ReCharge Clinical Trial
This trial is active, not recruiting.
|Treatments||active, implantable, intra abdominal vagal blocking medical device (maestro rc2 system)|
|Start date||May 2011|
|End date||December 2012|
|Trial size||234 participants|
|Trial identifier||NCT01327976, D01088|
To determine the safety and efficacy of the Maestro RC2 System in producing weight loss in obese subjects.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||Scottsdale Healthcare Bariatric Center||no longer recruiting|
|LaJolla, CA||Scripps Clinic Nutrition & Metabolic Research Center||no longer recruiting|
|Stanford, CA||Stanford University||no longer recruiting|
|Boston, MA||Tufts Medical Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Rochester, MN||Mayo Clinic Rochester||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Richmond, VA||Virginia Commonwealth University||no longer recruiting|
|Baulkham Hills, Australia||Institute of Weight Control||no longer recruiting|
|Bedford Park, SA, Australia||Adelaide Bariatric Centre||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Primary efficacy objective
time frame: 12 months
Primary safety objective
time frame: 12 months
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. - Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last 5 yrs. - 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||ReCharge Clinical Trial|
|Principal investigator||Michael Sarr, M.D.|
|Description||The Maestro RC2 System is a neuromodulation system. All subjects will be randomized in a 2:1 allocation to treatment or control group. All subjects will be followed through the 12-month follow-up visit. Subjects in the control group who choose to have an active device will undergo a second surgery.|
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