Robot-Assisted hernia surgery under study for safety and success
NCT ID NCT06445504
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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206 people
The number who actually took part.
- Started
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Apr 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bon Secours
Newport News, Virginia, 23602, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Duke University
Durham, North Carolina, 27705, United States
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Tampa General Hospital
Tampa, Florida, 33606, United States
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UT Health
Houston, Texas, 77401, United States
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University of Buffalo
Buffalo, New York, 14260, United States
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University of Illinois, Chicago
Chicago, Illinois, 60612, United States
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Other studies related to the condition(s) this trial covers.
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