ORBERA365 Post-Marketing Clinical Follow-up Study
ORBERA365 Post-Marketing Clinical Follow-up Study
A prospective, multicenter, open-label, post-approval study of the safety and effectiveness
 of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and
 BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥
 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).
This is a prospective, multicenter, open label study of the safety and effectiveness of
 ORBERA365™ for use as an adjunct to behavioral modification for obese adults (BMI ≥ 27 kg/m2
 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI
 ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities). All study subjects will participate in a
 behavioral modification program for 52 weeks, which will include a low calorie diet as well
 as nutritional and behavior modification counseling. Subjects will have ORBERA365™ placed for
 up to 52 weeks.

 Evaluations while on treatment will be performed at baseline (pre-placement), Day 0
 (ORBERA365 placement) and during monthly clinic visits during the 1st 6 months of device
 therapy and at months 9 and ORBERA365 removal. All subjects will have a final study visit at
 12 months, or study exit, whichever comes first. Device removal will occur at 52 unless
 removed early by subject request and/or physician recommendation. Reasons for early removal
 may include, but are not limited to, adverse events, subject dissatisfaction or achievement
 of weight loss goal.
Inclusion Criteria:

 1. Male and female adult subjects;

 2. BMI ≥ 27 kg/m2 and ≤ 50 kg/m2 if treatment is for temporary use for weight loss in
 subjects who failed to achieve and maintain weight loss with a supervised
 weight-control program;

 3. BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities, if treatment is for pre-surgical
 temporary use for weight loss in order to reduce surgical risk

 4. Be willing to commit to a long-term supervised diet and behavior modification program
 designed to increase the possibility of long-term weight loss maintenance;

 5. Be able to follow the requirements outlined in the protocol, including complying with
 the visit schedule;

 6. Be able to provide written informed consent;

 Exclusion Criteria:

 1. Presence of more than one ORBERA365 System Balloon at the same time;

 2. Prior surgery of the esophagus, stomach, or duodenum;

 3. Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis,
 gastric ulceration, duodenal ulceration, cancer or specific inflammation such as
 Crohn's disease;

 4. Has any upper gastrointestinal bleeding conditions such as esophageal or gastric
 varices, congenital or acquired intestinal telangiectasis, or other congenital
 anomalies of the GI tract such as atresias or stenosis;

 5. Has a large hiatal hernia or hernia > 5 cm;

 6. Has a structural abnormality in the esophagus or pharynx such as a stricture or
 diverticulum that could impede passage of the delivery catheter and/or an endoscope;

 7. Has any other medical condition which would not permit elective endoscopy, such as
 poor general health or history and/or symptoms of severe renal, hepatic, cardiac,
 and/or pulmonary disease;

 8. Has serious or uncontrolled psychiatric illness or disorder that could compromise
 subject understanding of or compliance with follow-up visits and removal of the
 device;

 9. Alcoholism or drug addiction;

 10. Unwilling to participate in an established medically-supervised diet and behavior
 modification program, with routine medical follow-up;

 11. Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other
 gastric irritants routinely and not under medical supervision;

 12. Females who are pregnant, nursing, or planning a pregnancy within the next year;

 13. Known to have, or suspected, allergy to materials contained in ORBERA365;

 14. Participation in previous (within 60 days of study day 1) or ongoing clinical trial or
 current or past usage (within 60 days of study day 1) of investigational drug or
 device, or any use of an intragastric balloon prior to this study;

 15. Genetically caused obesity;

 16. Prior intragastric balloon therapy, bariatric surgery or considering bariatric surgery
 during the study;

 17. Has a condition or is in a situation which in the Investigator's opinion may put the
 subject at significant risk or may interfere significantly with the subject's
 participation in the study.

 18. Known gastrointestinal motility disorders, especially known delayed gastric emptying

 19. Chronic use of anticholinergic medications and psychotropic medications known to delay
 gastric emptying.