Safety and Performance of the OTTAVA Robotic System

Inclusion criteria

Criteria for Inclusion: 1. Willing and able to provide informed consent; 2. Scheduled for an elective primary RYGB surgical procedure; 3. American Society of Anesthesiologists classification ≤ ASA III; 4. Body habitus such that the procedure can be safely completed with OTTAVA Robotic System; 5. Body weight \<500 lb (227 kg); 6. Patient presenting with class 2 or 3 obesity (BMI ≥ 35), regardless of comorbidities, or obesity with health risk satisfying 2022 ASMBS/IFSO indications for bariatric surgery; and 7. A minimum of 21 years of age (at time of consent). Criteria for Exclusion: 1. Surgeon determination that there is a medical condition, that makes surgery too risky, including intraoperative finding; 2. Concomitant surgical procedure including cholecystectomy (hiatal hernia repair up to 5 cm and adhesiolysis allowed); 3. Upper abdominal surgery within two years prior to enrollment (prior laparoscopic cholecystectomy allowed); 4. Evidence of hiatal hernia \>5 cm (preoperative/intraoperative); 5. Enrolled in another investigational study that may confound the results of this study; 6. Emergency surgery; 7. Active pregnancy; or 8. Subject from a vulnerable population, including anyone unable to adequately provide informed consent.