The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

1. Concurrent chronic pancreatic disease.

2. History of Crohn's disease and/or ulcerative colitis.

3. History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).

4. History of pulmonary embolism or blood coagulation disorders.

5. Clinically significant hiatal hernias (\> 5 cm) known from subject's medical record or determined by barium swallow (upper GI x-ray) or upper endoscopy per PI discretion prior to implant.

6. Current cirrhosis, portal hypertension and/or esophageal varices.

7. Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.

8. Treatment with prescription weight-loss drug therapy within the prior three months and the use of prescription drug therapy or the use of over-the-counter weight loss preparations for the duration of the trial.

9. Smoking cessation within the prior six months.

10. Known genetic cause of obesity (e.g., Prader-Willi Syndrome).

11. Weight loss of more than 10% of body weight in the previous 12 months.

12. Physician-prescribed diet with intent to lose weight prior to surgery (note:

study subject may continue any personal eating plan they were on prior to study enrollment \[see exclusion criterion #24\]

13. Current type 1 diabetes mellitus (DM).

14. Current or recent history (within 12 months) of ongoing bulimia.

15. Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).

16. Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).

17. Current treatment for peptic ulcer disease (previous history acceptable).

18. Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).

19. Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable).

20. 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.

21. Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators, neurostimulators etc.).

22. Planned or contemplated use of Magnetic Resonance Imaging (MRI) or oncologic radiation during the course of the trial.

23. Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, bulimia nervosa, etc.) or limited intellectual functioning which would potentially compromise the participant's ability to fully comprehend and/or cooperate with the study protocol. Psychiatric disorders will be established by a review of subject's medical history. For depression, a BDI (Beck Depression Inventory) score ≥ 29 will be considered to indicate severe depression.

24. Current, active member of an organized weight loss program (e.g., Weight Watchers, TOPS).

25. Current participant in another weight loss study or other clinical trials.

26. Have a friend or family member who is currently participating or is planning to participate in this clinical trial.

27. Patient reported:

* inability to walk for about 10 minutes without stopping,

* feeling of pain in chest when doing physical activity,

* feeling of pain in chest when not doing physical activity. Note: unless pain in chest in known to be related to upper gastrointestinal disorders such as gastroesophageal reflux disease or heartburn.

28. Clinically significant cardiac rhythm disorder that requires either medical and/or surgical intervention (e.g., paroxysmal or chronic atrial fibrillation).

What this study is about