Recruiting

OTTAVA System

Sponsor:

Auris Health, Inc.

Code:

NCT07298317

Conditions

Hernia, Inguinal

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

OTTAVA Robotic System

Study Details

Brief 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).

Conditions

Hernia, Inguinal

Study ID

NCT07298317

Start date

Mar 11, 2026

Status verified date

Aug, 2026

Completion date

Aug 21, 2026

Anticipated

Primary completion date

Aug 4, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria

Subjects must satisfy all inclusion criteria to be eligible for enrollment:

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

Exclusion Criteria

Subjects who meet any of the exclusion criteria may not be enrolled:

1. Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery
2. Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh
3. Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)
4. Previous radical prostatectomy procedure or pelvic irradiation
5. Hernia with significant scrotal involvement
6. Emergency surgery
7. Enrolled in another investigational study that may confound the results of this study
8. Currently pregnant or will be pregnant at time of procedure
9. Subject from a vulnerable population, including anyone unable to adequately provide informed consent.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OTTAVA Robotic System

Participants scheduled to undergo a non-emergent inguinal hernia repair (IHR) procedure, and who meet all study eligibility criteria, will be enrolled to receive the IHR procedure with OTTAVA Robotic System. After the hospital discharge, participants will undergo follow-up visits according to the institution's standard of care and complete a final follow-up visit at 30 days post-procedure.

Interventions

OTTAVA Robotic System

Participants will undergo the IHR procedure using OTTAVA Robotic System.

Primary outcome measure

  • Number of Participants Achieving Procedure Completion Without Conversion [ Time Frame: 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 [ Time Frame: Intraoperative through 30 days post-procedure ]

Central Contacts and Locations

Central contacts

Damaris Pederson, MPH

1 619 708 2607Dpeders@its.jnj.com

Dominic Papandria, MD

16509226723DPapandr@ITS.JNJ.com

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Indiana University North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Duke Regional Hospital

Recruiting

Durham, North Carolina, United States, 27704

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Auris Health, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Auris Health, Inc. on 2026-08-31.