Clinical Trial

Safety and Performance of the OTTAVA Robotic System

Study acronym: FORTE
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 changes
critical Trial status changed: Withheld → Completed 2026-08-14
critical Phase changed: not specified -> not applicable 2026-08-14
critical Primary endpoint(s) modified 2026-08-14
notable Enrollment changed: None -> 32 2026-08-14
notable Sponsor changed: [Redacted] -> Auris Health, Inc. 2026-08-14
minor Trial arms changed: 0 -> 1 2026-08-14
notable Trial sites expanded: 0 -> 6 locations 2026-08-14
Trial Details
NCT Number NCT06709261
Lead Sponsor Auris Health, Inc.
Conditions Obesity
Enrollment 32 participants
Start Date 2025-02-05
Primary Completion 2025-10-20 (estimated)
Study Completion 2025-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-13