Inguinal Hernia, Ventral Hernia
Conditions
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).
Interventions
DEVICERobotic-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
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Greenberg, MD
Duke University
Participant flow
Recruitment details
There was no minimum enrollment requirement at each site. A single study site was allowed to treat no more than 30% of the total population. 193 subjects from 7 US sites contributed to the study.
Pre-assignment details
A total of 206 subjects were consented for enrollment. Thirteen subjects were discontinued from the study prior to the procedure.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 13.23 |
| BMI | 28.4 kg/m2 STANDARD_DEVIATION 4.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Height | 175.1 cm STANDARD_DEVIATION 9.04 |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 21 Participants |
| Race/Ethnicity, Customized Multiracial/multicultural | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants |
| Race/Ethnicity, Customized White | 77 Participants |
| Region of Enrollment United States | 193 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 89 Participants |
| Weight | 87.5 kg STANDARD_DEVIATION 17.39 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 96 |
| other Total, other adverse events | 24 / 97 | 24 / 96 |
| serious Total, serious adverse events | 3 / 97 | 5 / 96 |
Outcome results
None listed