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

NCT07298317 | Recruiting FDA Device

• 1 other identifier: EDS202402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Achieving Procedure Completion Without Conversion

  Number of participants achieving procedure completion without conversion will be reported.

  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

  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.

  Intraoperative through 30 days post-procedure

Secondary Outcomes (9)

• Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure

  Up to 30 days post-procedure

• Total Operative Time

  Intraoperative

• Number of Participants Needing Blood Transfusion

  Intraoperative, Up to 30 days post-procedure

• Number of Units of Blood Transfusion

  Intraoperative, Up to 30 days post-procedure

• Number of Participants Experiencing Device Malfunction

  Intraoperative

Study Arms (1)

OTTAVA Robotic System

EXPERIMENTAL

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.

Device: OTTAVA Robotic System

Interventions

OTTAVA Robotic System DEVICE

Participants will undergo the IHR procedure using OTTAVA Robotic System.

OTTAVA Robotic System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Auris Health, Inc.: lead

Study Sites (4)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Indiana University North Hospital

Carmel, Indiana, 46032, United States

RECRUITING

Duke Regional Hospital

Durham, North Carolina, 27704, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Auris Health, Inc. Clinical Trial

  Auris Health, Inc.

  STUDY DIRECTOR

Central Study Contacts

Damaris Pederson, MPH

CONTACT

1 619 708 2607; Dpeders@its.jnj.com

Dominic Papandria, MD

CONTACT

16509226723; DPapandr@ITS.JNJ.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start: March 11, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4)