Inguinal HerniaNCT06445504
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
A study testing Robotic-Assisted Surgery (RAS) Hernia Repair Surgery in people with Inguinal Hernia and Ventral Hernia, run by Medtronic - MITG at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Inguinal Hernia, Ventral Hernia
- What is being tested?
- Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Apr 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Buffalo
Buffalo, New York, 14260
University of Illinois, Chicago
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27705
UT Health
Houston, Texas, 77401
Bon Secours
Newport News, Virginia, 23602
Tampa General Hospital
Tampa, Florida, 33606
About this study
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 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).
- Conditions
- Inguinal Hernia, Ventral Hernia
- Being tested
- Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Surgery (RAS) Hernia Repair SurgeryDevice
Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Surgery (RAS) Hernia Repair Surgery | Experimental | Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system Receives: Device: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 30 Days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 30 Days
Secondary Endpoint - Operative Time
Minutes from skin incision to skin closure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start8 Apr 2024
- Primary completion19 Mar 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Greenberg, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445504
- Sponsor's protocol ID
- MDT21022
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2024
- Last updated
- 4 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Repair)
- ClinicalTrials.gov ID
- NCT06445504
- Acronym / sponsor ID
- MDT21022
- Conditions
- Inguinal Hernia, Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Posted 4 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Surgery (RAS) Hernia Repair Surgery | Experimental | Device: Robotic-Assisted Surgery (RAS) Hernia Repair SurgeryPatients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Surgery (RAS) Hernia Repair SurgeryPatients 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 |
Primary outcome
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.
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)
7 secondary outcomes
Secondary Endpoint - Rate of Subjects With Complications
Time frame: 30 Days
Secondary Endpoint - Rate of Subjects With Major Complications
Time frame: 30 Days
Secondary Endpoint - Operative Time
Time frame: Intraoperative
Secondary Endpoint - Rate of Subjects With Readmission
Time frame: 30 Days
Secondary Endpoint - Rate of Subjects With Reoperation
Time frame: 30 Days
Secondary Endpoint - Rate of Subjects With Recurrence
Time frame: 30 Days
Secondary Endpoint - Rate of Subjects With Recurrence Through 2 Years Post-procedure
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Greenberg, MD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Surgery (RAS) Hernia Repair Surgery in people with Inguinal Hernia and Ventral Hernia, run by Medtronic - MITG at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success (time frame: During surgical procedure, over an average of 81 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.