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.

Safety and Performance of the OTTAVA Robotic System

What this study is about