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Robot-Assisted hernia surgery under study for safety and success

NCT ID NCT06445504

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at how well a new robotic system (Medtronic Hugo™) works for fixing inguinal and ventral hernias. About 206 adults will have robotic hernia repair, and researchers will track if the surgery is completed without switching to another method and if any complications occur within 30 days. The goal is to see if the robot is a safe and effective tool for these common hernia repairs.

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

206 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Mar 2027

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: * Adult subjects (age ≥ 22 years) as required by local law * Subject has been indicated for one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). Multiple small hernia defects are allowed with total distance of combined defects being \< 10cm (b.) inguinal (unilateral or bilateral) hernia(s). * Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure * The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form Exclusion Criteria: * Patients for which minimally invasive surgery is contraindicated as determined by the Investigator * Patients with a recurrent hernia * Subjects with femoral hernia defects * Subjects with ventral hernia defect(s) located in M1, M5, or L4 * Patients with emergent hernia repair * Ventral hernia is CDC (Center for Disease Control) grade 2 or higher * Use of component separation techniques to close the hernia defect * Inability to close the hernia defect * Hernia defect is ≥ 10 cm * Patient has BMI \> 40 * Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator * Patients diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care * Female patients pregnant at the time of the surgical procedure. * Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity) * Patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study * Patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal Hernia, Ventral

As listed by the trial registrant

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

Contacts and locations

Locations

  • Bon Secours

    Newport News, Virginia, 23602, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • UT Health

    Houston, Texas, 77401, United States

  • University of Buffalo

    Buffalo, New York, 14260, United States

  • University of Illinois, Chicago

    Chicago, Illinois, 60612, United States

More trials for these conditions

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