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

NCT07298317 · tracked via the Priya Life Science USA tracker

Sponsor

Auris Health, Inc.

Phase

Not applicable

Started

2026-03-11

Last updated

2026-08-31

Condition(s) studied

Hernia, Inguinal

Investigational drug(s) / intervention(s)

OTTAVA Robotic System

OTTAVA Robotic System: Participants will undergo the IHR procedure using OTTAVA Robotic System.

Study 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).

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants Achieving Procedure Completion Without Conversion — Intraoperative
Number of participants achieving procedure completion without conversion will be reported.
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 — Intraoperative through 30 days post-procedure
The Clavien-Dindo classification for surgical complications provides a standardized, reproducible means for describing surgical complications based on described therapy for treatment. Clavien-Dindo grade III complications include those complications that require surgical, endoscopic, or radiological intervention. The interventions that are not given under general anesthesia are grade III A and the interventions given under general anesthesia are grade III B complications.

Trial sites (4)

Facility	City	Region	Status
Tampa General Hospital	Tampa	Florida	Recruiting
Indiana University North Hospital	Carmel	Indiana	Recruiting
Duke Regional Hospital	Durham	North Carolina	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	Recruiting

Other trials for the same condition

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot Active, not recruiting

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07298317 on ClinicalTrials.gov ↗ ← All trials in the USA