RecruitingNot Applicable

Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair

United States30 participantsStarted 2026-03-11

Plain-language summary

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 participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Willing and able to provide informed consent
. A minimum of 22 years old at time of consent
. Scheduled for elective primary inguinal hernia repair
. American Society of Anesthesiologists (ASA) classification I, II, or III
. Weight less than 227 kilograms (500 pounds)

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Achieving Procedure Completion Without Conversion

Timeframe: Intraoperative

Number of Participants Experiencing Intraoperative and Postoperative Device or Procedure-Related Complications Greater than or Equal to (>=) Clavien-Dindo Grade III through 30 Days Post-Procedure

Timeframe: Intraoperative through 30 days post-procedure

Trial details

NCT IDNCT07298317

SponsorAuris Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Damaris Pederson, MPH

1 619 708 2607 Dpeders@its.jnj.com

View on ClinicalTrials.gov More Hernia, Inguinal trials