Hernia, InguinalTEMPONCT07298317
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
A study testing OTTAVA Robotic System in people with Hernia, Inguinal, run by Auris Health, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- OTTAVA Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Mar 2026to 3 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy all inclusion criteria to be eligible for enrollment:
- 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)
Who cannot join
- Subjects who meet any of the exclusion criteria may not be enrolled:
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University North Hospital
Carmel, Indiana, 46032
Duke Regional Hospital
Durham, North Carolina, 27704
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System
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
- Being tested
- OTTAVA Robotic System
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTTAVA Robotic SystemDevice
Participants will undergo the IHR procedure using OTTAVA Robotic System.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OTTAVA Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Procedure Completion Without Conversion
Number of participants achieving procedure completion without conversion will be reported.
Measured: 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.
Measured: Intraoperative through 30 days post-procedure
Secondary outcomes (9)
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.
Measured: 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.
Measured: Intraoperative
Number of Participants Needing Blood Transfusion
Number of participants needing blood transfusions will be reported.
Measured: Intraoperative, Up to 30 days post-procedure
Number of Units of Blood Transfusion
Number of units of blood transfusion will be reported.
Measured: 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.
Measured: Intraoperative
Length of Hospital Stay
The length of hospital stay from the date of procedure until discharge will be reported.
Measured: 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.
Measured: 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.
Measured: Up to 30 days post-procedure
Mortality
Number of mortalities will be reported.
Measured: Intraoperative, Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start11 Mar 2026
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auris Health, Inc. Clinical Trial, Study director, Auris Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298317
- Sponsor's protocol ID
- EDS202402
- Acronym
- TEMPO
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System
- ClinicalTrials.gov ID
- NCT07298317
- Acronym / sponsor ID
- TEMPO / EDS202402
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Auris Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTTAVA Robotic System | Experimental | Device: OTTAVA Robotic SystemParticipants 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTTAVA Robotic SystemParticipants will undergo the IHR procedure using OTTAVA Robotic System. | Device | OTTAVA Robotic System |
Primary outcome
Number of Participants Achieving Procedure Completion Without Conversion
Time frame: 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
Time frame: 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.
9 secondary outcomes
Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure
Time frame: Up to 30 days post-procedure
Total Operative Time
Time frame: Intraoperative
Number of Participants Needing Blood Transfusion
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Units of Blood Transfusion
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Participants Experiencing Device Malfunction
Time frame: Intraoperative
Length of Hospital Stay
Time frame: Intraoperative, Up to 30 days post-procedure
Number of Participants with Hospital Readmission
Time frame: Up to 30 days post-procedure
Number of Participants with Reoperations
Time frame: Up to 30 days post-procedure
Mortality
Time frame: Intraoperative, Up to 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Auris Health, Inc. Clinical Trial study director
Auris Health, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTTAVA Robotic System in people with Hernia, Inguinal, run by Auris Health, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Procedure Completion Without Conversion (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.