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Safety and Performance of the OTTAVA Robotic System

CompletedNA

Sponsor: Auris Health, Inc.

Conditions: Obesity

Interventions: OTTAVA Robotic System

Countries: United States

This study assesses safety and performance of the OTTAVA Robotic System, through 30 days postoperative, in subjects undergoing robotic-assisted Roux-en-Y Gastric Bypass (RYGB) procedure.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (6)

Orlando, Florida, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Mineola, New York, United States
Durham, North Carolina, United States
Bellaire, Texas, United States