Safety and Performance of the OTTAVA Robotic System

Criteria the registry did not label

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