🏛️ Verified NIH Record • Updated 2026-08-03
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair (NCT07298317)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Auris Health, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).
Location: Tampa General Hospital — Tampa, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria Subjects who meet any of the exclusion criteria may not be enrolled:
- Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery
- Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh
- Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)
- Previous radical prostatectomy procedure or pelvic irradiation
- Hernia with significant scrotal involvement
- Emergency surgery
- Enrolled in another investigational study that may confound the results of this study
- Currently pregnant or will be pregnant at time of procedure
- Subject from a vulnerable population, including anyone unable to adequately provide informed consent.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Tampa General Hospital — Tampa, Florida
- Indiana University North Hospital — Carmel, Indiana
- Duke Regional Hospital — Durham, North Carolina
- The University of Texas Health Science Center at Houston — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.