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

• 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

• Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success [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.
• Primary Safety Endpoint - Rate of Subjects With Surgical Site Event [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

• Secondary Endpoint - Rate of Subjects With Complications [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.
• Secondary Endpoint - Rate of Subjects With Major Complications [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.
• Secondary Endpoint - Operative Time [Intraoperative]: Minutes from skin incision to skin closure.
• Secondary Endpoint - Rate of Subjects With Readmission [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.
• Secondary Endpoint - Rate of Subjects With Reoperation [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.
• Secondary Endpoint - Rate of Subjects With Recurrence [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.
• Secondary Endpoint - Rate of Subjects With Recurrence 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.

Sex: All, ages: 22 Years to any

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

Participant flow

Outcome results

• Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success (Primary), Count of participants, Participants: Robotic Assisted Surgery (RAS) Hernia Repair 193 (p <0.0001)
• Primary Safety Endpoint - Rate of Subjects With Surgical Site Event (Primary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 0; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 2 (p <0.0001)
• Secondary Endpoint - Rate of Subjects With Complications (Secondary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 33; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 40
• Secondary Endpoint - Rate of Subjects With Major Complications (Secondary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 0; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 1
• Secondary Endpoint - Operative Time (Secondary), Mean, Minutes: Robotic Assisted Surgery (RAS) - Inguinal Unilateral Hernia Repair 72 +/- 31.3; Robotic Assisted Surgery (RAS) - Inguinal Bilateral Hernia Repair 121 +/- 43.4; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 79 +/- 30.7
• Secondary Endpoint - Rate of Subjects With Readmission (Secondary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 1; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 4
• Secondary Endpoint - Rate of Subjects With Reoperation (Secondary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 0; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 1
• Secondary Endpoint - Rate of Subjects With Recurrence (Secondary), Count of participants, Participants: Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair 0; Robotic Assisted Surgery (RAS) - Ventral Hernia Repair 0
• Secondary Endpoint - Rate of Subjects With Recurrence Through 2 Years Post-procedure (Secondary)

Adverse events

Time frame: All Adverse Events were collected from the time of consent through 30 days post procedure.

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2025-09-02)
• Statistical Analysis Plan (PDF, 2025-12-19)

• Jacob Greenberg, MD, Principal investigator, Duke University