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

A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Inguinal and Ventral Hernia Repair Surgery (Enable Hernia Repair)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia; Ventral Hernia
• Intervention / Treatment: Device: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois, Chicago
  • New York
    • Buffalo, New York, United States, 14260
      • University of Buffalo
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Houston, Texas, United States, 77401
      • UT Health
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Bon Secours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint - Rate of Subjects With Complications	Overall rate of subjects with one or more procedure- and/or device-related complications (Clavien-Dindo Grade I or higher), from the time of the first incision through 30 days post-procedure.	30 Days
Secondary Endpoint - Rate of Subjects With Major Complications	Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the time of the first incision through 30 days post-procedure.	30 Days
Secondary Endpoint - Operative Time	Minutes from skin incision to skin closure.	Intraoperative
Secondary Endpoint - Rate of Subjects With Readmission	Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.	30 Days
Secondary Endpoint - Rate of Subjects With Reoperation	Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.	30 Days
Secondary Endpoint - Rate of Subjects With Recurrence	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.	30 Days
Secondary Endpoint - Rate of Subjects With Recurrence Through 2 Years Post-procedure	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.	2 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Device- and/or procedure-related AEs through 2 years.	2 Years
Hospital length of stay	Hospital length of stay.	30 Days
Mortality rate	All cause mortality.	30 Days
Surgeon experience	Surgeon experience survey collected after the first procedure and after the tenth procedure. If the surgeon conducts fewer than ten procedures in the study, the second survey will be conducted after the final procedure.	30 Days
Pain scores	Collecting ACHQC questionnaire (numerical scale where the higher the score, the greater the pain) at baseline, 30 days, and 3 months.	3 Months
Transfusion rate	Transfusion rate through 30 days.	30 Days
Blood loss	Estimated intraoperative blood loss.	Intraoperative
Readmission rate through 2 years	Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.	2 Years
Reoperation rate through 2 years	Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.	2 Years

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Jacob Greenberg, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Actual): March 19, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal; Hernia, Ventral; Surgical Procedures, Operative; Technology, Industry, and Agriculture; Automation; Technology; Surgery, Computer-Assisted; Robotics; Robotic Surgical Procedures
• Other Study ID Numbers: MDT21022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes