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

NCT06445504 | Active Not Recruiting Results FDA Device

• 1 other identifier: MDT21022
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 7

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

Ventral Hernia; Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success

  The primary effectiveness endpoint is rate of subjects who have surgical success, with surgical success defined as the procedure not going into conversion. Conversion is defined as the switch from the robotic-assisted approach using the Hugo™ RAS system to laparoscopic, open surgery, or use of an alternative robotic-assisted system.

  During surgical procedure, over an average of 81 minutes

• Primary Safety Endpoint - Rate of Subjects With Surgical Site Event

  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)

  30 Days

Secondary Outcomes (7)

• Secondary Endpoint - Rate of Subjects With Complications

  30 Days

• Secondary Endpoint - Rate of Subjects With Major Complications

  30 Days

• Secondary Endpoint - Operative Time

  Intraoperative

• Secondary Endpoint - Rate of Subjects With Readmission

  30 Days

• Secondary Endpoint - Rate of Subjects With Reoperation

  30 Days

Study Arms (1)

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

EXPERIMENTAL

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

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

Interventions

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery 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

Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (7)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

University of Buffalo

Buffalo, New York, 14260, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UT Health

Houston, Texas, 77401, United States

Location

Bon Secours

Newport News, Virginia, 23602, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Ventral

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Shenita Bolstrom, Clinical Study Manager
• Organization: Medtronic

shenita.bolstrom@medtronic.com

763-541-4000

Study Officials

• Jacob Greenberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: June 6, 2024
• Study Start: April 8, 2024
• Primary Completion: March 19, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Locations

US (7)