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Completed
NCT06709261
Safety and Performance of the OTTAVA Robotic System
Conditions: Obesity
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Auris Health, Inc.
Location: Orlando Health Orlando Florida
Summary
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 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 \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.
Source: ClinicalTrials.gov (NCT06709261). StuddyBuddy aggregates publicly available trial information.
