An interventional study of OTTAVA Robotic System in Hernia, Inguinal, sponsored by Auris Health, Inc.. Completed at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 77 studies in Hernia, Inguinal with a site in United States — 9 open to participants now, 20 under way, none of them phase 3. Hernia, Inguinal · United States.
Among the 77 studies in Hernia, Inguinal with a site in United States, this one is the 51st largest by enrollment of the 60 interventional ones that give a count, is one of 5 that started in 2026, is one of 36 with no phase, and was the 74th registered.
544 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
Browse Hernia, Inguinal studies →9 of the 77 studies in Hernia, Inguinal with a site in United States are open now. Recruiting first, the newest first:
Northwestern University · Sites in United States
Ages 18+
Northwestern University · Sites in United States
Ages 50+ · Men only
Northwestern University · Sites in United States
Ages 18+
Distalmotion SA · Sites in United States
Ages 22+
University of Michigan · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 56 Hernia, Inguinal studies recruiting now, 30 (54%) set no upper age limit and 17 (30%) stop at 75 or younger; 16 take children under 18; 9 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 7 · Phase 4 10
First in 1987; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 90 across 396 interventional studies indexed under Hernia, Inguinal.
Median enrollment 100 across the 60 interventional studies, 116 across the 17 observational. Of the 50 that completed or were terminated, 24 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 77 have an industry lead sponsor. The 10 most frequent:
This study is registered under Auris Health, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Auris Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Johnson & Johnson has 2 studies filed under Hernia, Inguinal — fewer than ten, so there is no comparison to draw.
4 of the studies in Hernia, Inguinal with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06934564University of MichiganDe-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery | 2026-12 |
| NCT04779918Tela Bio IncVentral or Inguinal Hernia, Robotically Repaired With OviTex Mesh | 2027-03-30 |
| NCT05388929Prisma Health-UpstateMethocarbamol in Ventral and Inguinal HR | 2027-06 |
| NCT05929937Clayton PetroNo Opioids vs. Minimal Opioids Following Inguinal Hernia Repair | 2027-06 |
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Among the 77 studies in Hernia, Inguinal with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Ran from Mar 2026 to primary completion in Aug 2026, 4 months.
Of 187 interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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