EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

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 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.

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 (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 mont