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Secret device trial raises questions

NCT ID NCT07298317

Knowledge-focused Sponsor: Auris Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 7 times

Summary

This trial is studying a device that has not been approved by the U.S. FDA. The purpose is to learn more about how the device works and its potential effects. Participant details and key results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hernia, inguinal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke Regional Hospital

    RECRUITING

    Durham, North Carolina, 27704, United States

  • Indiana University North Hospital

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.