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Safety and Performance of the OTTAVA Robotic System
Sponsor: Auris Health, Inc.
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.
Official title: EDS-2022-01: Safety and Performance of the OTTAVA™ Robotic System: A Prospective, Multi-Center Evaluation (FORTE)
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-02-05
Completion Date
2025-10-20
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
OTTAVA Robotic System
Procedure with the OTTAVA Robotic System
Locations (6)
Orlando Health
Orlando, Florida, United States
University of South Florida Tampa General Hospital
Tampa, Florida, United States
IU Health North Hospital
Indianapolis, Indiana, United States
NYU Long Island
Mineola, New York, United States
Duke Regional Hospital
Durham, North Carolina, United States
UT Health Houston and Memorial Hermann TMC
Bellaire, Texas, United States