Medtronic Hugoâ„¢ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair) (NCT06445504) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Medtronic Hugoâ„¢ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
United States206 participantsStarted 2024-04-08
Plain-language summary
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 Hugoâ„¢ 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).
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 su…
What they're measuring
1
Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success
Timeframe: During surgical procedure, over an average of 81 minutes
2
Primary Safety Endpoint - Rate of Subjects With Surgical Site Event