FORTE-Safety and Performance of the OTTAVA Robotic System: A Prospective, Multi-Center Evaluation
Safety and Performance of the OTTAVA Robotic System: A Prospective, Multi-Center Evaluation (FORTE)
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Clinical Trial Information
Trial Contact: Morales, Leticia; Hernandez-Pagan, Gloryvee
Trial Phone: 321.841.9623 ; 321-843-8910
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IRB No: 25.140.06
Protocol Abbrev: FORTE
Principal Investigator: Andre F. Teixeira, MD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: EDS_2022_01
Treatment: OTTAVA robotic system
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT06709261
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Objective
The study will assess safety and performance of the OTTAVA Robotic System, through 30 days postoperative, in subjects undergoing robotic-assisted Roux-en-Y Gastric Bypass (RYGB) procedure.
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Key Eligibility
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).
