An interventional study of OTTAVA Robotic System in Hernia, Inguinal, sponsored by Auris Health, Inc.. Recruiting at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Auris Health, Inc. · Not applicable, Interventional, and Treatment
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).
Subjects must satisfy all inclusion criteria to be eligible for enrollment:
Exclusion Criteria
Subjects who meet any of the exclusion criteria may not be enrolled:
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
Participants will undergo the IHR procedure using OTTAVA Robotic System.
Number of Participants Achieving Procedure Completion Without Conversion
Number of participants achieving procedure completion without conversion will be reported.
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
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.
Time frame: Intraoperative through 30 days post-procedure
Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
Time frame: Up to 30 days post-procedure
Total Operative Time
Total procedure time is defined by the time taken for the procedure, that is, from skin incision to skin closure.
Time frame: Intraoperative
Number of Participants Needing Blood Transfusion
Number of participants needing blood transfusions will be reported.
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Units of Blood Transfusion
Number of units of blood transfusion will be reported.
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Participants Experiencing Device Malfunction
Device malfunction is defined as a failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or clinical investigation plan.
Time frame: Intraoperative
Length of Hospital Stay
The length of hospital stay from the date of procedure until discharge will be reported.
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Participants with Hospital Readmission
Number of participants getting admitted to hospital again after discharge within 30 days post-procedure will be reported.
Time frame: Up to 30 days post-procedure
Number of Participants with Reoperations
Number of participants with reoperations including any procedures performed within 30 days that are directly related to the index procedure will be reported.
Time frame: Up to 30 days post-procedure
Mortality
Number of mortalities will be reported.
Time frame: Intraoperative, Up to 30 days post-procedure
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
No publications or documents are linked to this record.
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Auris Health, Inc.