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

Not Applicable

Active, not recruiting

• Conditions: Inguinal Hernia; Ventral Hernia

• Registration Number: NCT06445504
• Lead Sponsor: Medtronic - MITG

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-01
• Study Start: 2024-04-08
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-06
• Primary Completion: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Surgical success rate	2 Years	Rate of conversions from Hugo™ System to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
Surgical site event rate	2 Years	The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications: * Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention; * Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)

Secondary Outcome Measures

Name	Time	Method
Operative time	Intraoperative	Time from skin incision to skin closure.
Readmission rate through 30 days post-procedure	30 Days	Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.
Recurrence rate through 2 years post-procedure	2 Years	Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator. Suspected hernia recurrence(s) reported by a subject, but not confirmed by an investigator, will not be considered as a clinical hernia recurrence for this endpoint, but will be reported separately as a subject-reported recurrence.
Complication rate	30 Days	Overall rate of patients with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
Major Complication Rate	30 Days	Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the first incision through 30 days post-procedure.
Reoperation rate through 30 days post-procedure	30 Days	Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.
Recurrence rate through 30 days post-procedure	30 Days	Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator.

Trial Locations

Locations (7)

University of Buffalo; 🇺🇸 Buffalo, New York, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, 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