Safety and Performance of the OTTAVA Robotic System

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.