Clinical trial NCT06445504: Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Ventral Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 193
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Surgical success rate
timeFrame: 2 Years
measure: Surgical site event rate
timeFrame: 2 Years
Secondary outcomes:
measure: Complication rate
timeFrame: 30 Days
measure: Operative time
timeFrame: Intraoperative
measure: Major Complication Rate
timeFrame: 30 Days
measure: Readmission rate through 30 days post-procedure
timeFrame: 30 Days
measure: Reoperation rate through 30 days post-procedure
timeFrame: 30 Days
measure: Recurrence rate through 2 years post-procedure
timeFrame: 2 Years
measure: Recurrence rate through 30 days post-procedure
timeFrame: 30 Days
Other outcomes:
measure: Adverse Events (AEs)
timeFrame: 2 Years
measure: Hospital length of stay
timeFrame: 30 Days
measure: Mortality rate
timeFrame: 30 Days
measure: Surgeon experience
timeFrame: 30 Days
measure: Pain scores
timeFrame: 3 Months
measure: Transfusion rate
timeFrame: 30 Days
measure: Blood loss
timeFrame: Intraoperative
measure: Readmission rate through 2 years
timeFrame: 2 Years
measure: Reoperation rate through 2 years
timeFrame: 2 Years
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: UT Health
state: Texas
city: Newport News
country: United States
facility: Bon Secours
state: Virginia
Study officials:
affiliation: Duke University
name: Jacob Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: