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

Medtronic

Status: Active, not recruiting

Conditions: Ventral Hernia; Inguinal Hernia

Treatments: Device: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT06445504

MDT21022

Details and patient eligibility

About

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).

Enrollment: 193 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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193 participants in 1 patient group

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

Experimental group

Description:

Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system

Treatment:

Device: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery