EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00521079

Run by

ReShape Lifesciences

People needed

294

Starts

2007-08-01

Expected to finish

2018-05-01

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:
• Type 2 diabetes mellitus (note: type 2 diabetics are allowed at selected centers only, see Inclusion criterion #5)
• Hypertension as defined by systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg a) treated or untreated with systolic ≥140 mmHg or diastolic ≥90 mmHg or b) treated with systolic <140 mmHg and diastolic <90 mmHg
• Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130 a) treated or untreated with total cholesterol ≥200 or LDL ≥130 or b) treated with total cholesterol <200 or LDL <130
• Sleep apnea syndrome (confirmed by overnight p02 studies)
• Obesity related cardiomyopathy
• Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
• 18-65 years of age inclusive.
• Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:
• Glycosylated hemoglobin (Hb A1c) 6.5 - 9 % inclusive at screening visit.
• Onset: 10 years or less since initial diagnosis.
• Stable treatment regimen: no change in oral hypoglycemic treatment regimen within past 3 months.
• Currently not using insulin therapy, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin) for diabetes treatment and have not been on these treatments in the past 6 months.
• Creatinine within normal reference range.
• No history of proliferative retinopathy.
• No history of peripheral neuropathy.
• No history of autonomic neuropathy.
• No history of coronary artery disease, with or without angina pectoris.
• No history of peripheral vascular disease.
• Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months within the last five years.
• Ability to complete all study visits and procedures.

You may not qualify if…

• 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 (acceptable surgeries include cholecystectomy, hysterectomy).
• 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 if they have not had one done during the previous 6 months that specifically reported on the presence or absence of hiatal hernia making reference to the Z-line and/or diaphragmatic notch, in order to rule out subjects with hiatal hernia that may require surgical repair (to support exclusion criterion #7).
• 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 (e.g., Prader-Willi Syndrome).
• Overall sustained reduction of more than 10% of body weight in the previous 12 months.
• Physician-prescribed pre-operative diet with intent to lose weight prior to surgery (note: a) study subject may continue any personal diet they were on prior to study enrollment [see exclusion criterion #24] b) standardized EMPOWER weight management program to be initiated in all subjects at time of activation, approximately two weeks after implant)
• Current type 1 diabetes mellitus (DM).
• Current or recent history (within 12 months) of ongoing bulimia.
• Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).
• Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).
• Current treatment for peptic ulcer disease (previous history acceptable).
• Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).
• Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable).
• Current medical condition that, in the opinion of the investigator, would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or recent serious trauma.
• Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators, neurostimulators etc.).
• Planned or contemplated use of Magnetic Resonance Imaging (MRI) or oncological radiation during the course of the trial.
• Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject's ability to follow study procedures and/or instructions.
• Current, active member of an organized weight loss program (e.g., Weight Watchers, TOPS).
• Current participant in another weight loss study or other clinical trials.

Where it is running

• 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
• Johns Hopkins — Baltimore, Maryland, 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 — St Louis, Missouri, United States
• Cleveland Clinic - Ohio — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Institute of Weight Control — Sydney, New South Wales, Australia
• Adelaide Bariatric Center - Flinders Private Hospital — Bedford Park, South Australia, Australia

Full record on ClinicalTrials.gov

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