Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06445504

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventral Hernia

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success

    Time frame: During surgical procedure, over an average of 81 minutes

    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.

  2. Primary Safety Endpoint - Rate of Subjects With Surgical Site Event

    Time frame: 30 Days

    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 outcomes

  1. Secondary Endpoint - Rate of Subjects With Complications

    Time frame: 30 Days

    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.

  2. Secondary Endpoint - Rate of Subjects With Major Complications

    Time frame: 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 time of the first incision through 30 days post-procedure.

  3. Secondary Endpoint - Operative Time

    Time frame: Intraoperative

    Minutes from skin incision to skin closure.

  4. Secondary Endpoint - Rate of Subjects With Readmission

    Time frame: 30 Days

    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.

  5. Secondary Endpoint - Rate of Subjects With Reoperation

    Time frame: 30 Days

    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.

  6. Secondary Endpoint - Rate of Subjects With Recurrence

    Time frame: 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.

  7. Secondary Endpoint - Rate of Subjects With Recurrence Through 2 Years Post-procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.