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

NCT ID: NCT06445504

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2027-03-15

Brief 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 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).

Conditions

Inguinal Hernia; Ventral Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

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

Group Type: EXPERIMENTAL

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

Intervention Type: DEVICE

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

Interventions

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

Countries

United States

Other Identifiers

MDT21022

Identifier Type: -

Identifier Source: org_study_id