Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)

Running, not enrolling · Not applicable

Conditions studied: Inguinal Hernia, Ventral Hernia

In brief

A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).

Key facts

Study ID

NCT06445504

Run by

Medtronic - MITG

People needed

206

Starts

2024-04-08

Expected to finish

2027-03-01

Last updated by the study team

2026-05-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tampa General Hospital — Tampa, Florida, United States
• University of Illinois, Chicago — Chicago, Illinois, United States
• University of Buffalo — Buffalo, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Health — Houston, Texas, United States
• Bon Secours — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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