Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-04 @ 7:03 PM
Study NCT ID:
NCT06445504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': '2 Years', 'description': 'Device- and/or procedure-related AEs through 2 years.'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 Days', 'description': 'Hospital length of stay.'}, {'measure': 'Mortality rate', 'timeFrame': '30 Days', 'description': 'All cause mortality.'}, {'measure': 'Surgeon experience', 'timeFrame': '30 Days', 'description': 'Surgeon experience survey collected after the first procedure and after the tenth procedure. If the surgeon conducts fewer than ten procedures in the study, the second survey will be conducted after the final procedure.'}, {'measure': 'Pain scores', 'timeFrame': '3 Months', 'description': 'Collecting ACHQC questionnaire (numerical scale where the higher the score, the greater the pain) at baseline, 30 days, and 3 months.'}, {'measure': 'Transfusion rate', 'timeFrame': '30 Days', 'description': 'Transfusion rate through 30 days.'}, {'measure': 'Blood loss', 'timeFrame': 'Intraoperative', 'description': 'Estimated intraoperative blood loss.'}, {'measure': 'Readmission rate through 2 years', 'timeFrame': '2 Years', 'description': 'Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.'}, {'measure': 'Reoperation rate through 2 years', 'timeFrame': '2 Years', 'description': 'Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.'}], 'primaryOutcomes': [{'measure': 'Surgical success rate', 'timeFrame': '2 Years', 'description': 'Rate of conversions from Hugo™ System to laparoscopic, open surgery, or use of an alternative robotic-assisted system.'}, {'measure': 'Surgical site event rate', 'timeFrame': '2 Years', 'description': '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:\n\n* 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\n* Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '30 Days', 'description': 'Overall rate of patients with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.'}, {'measure': 'Operative time', 'timeFrame': 'Intraoperative', 'description': 'Time from skin incision to skin closure.'}, {'measure': 'Major Complication Rate', 'timeFrame': '30 Days', 'description': 'Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the first incision through 30 days post-procedure.'}, {'measure': 'Readmission rate through 30 days post-procedure', 'timeFrame': '30 Days', 'description': 'Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.'}, {'measure': 'Reoperation rate through 30 days post-procedure', 'timeFrame': '30 Days', 'description': 'Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.'}, {'measure': 'Recurrence rate through 2 years post-procedure', 'timeFrame': '2 Years', 'description': '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.'}, {'measure': 'Recurrence rate through 30 days post-procedure', 'timeFrame': '30 Days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Inguinal Hernia', 'Ventral Hernia']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects (age ≥ 22 years) as required by local law\n* 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).\n* Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure\n* The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form\n\nExclusion Criteria:\n\n* Patients for which minimally invasive surgery is contraindicated as determined by the Investigator\n* Patients with a recurrent hernia\n* Subjects with femoral hernia defects\n* Subjects with ventral hernia defect(s) located in M1, M5, or L4\n* Patients with emergent hernia repair\n* Ventral hernia is CDC (Center for Disease Control) grade 2 or higher\n* Use of component separation techniques to close the hernia defect\n* Inability to close the hernia defect\n* Hernia defect is ≥ 10 cm\n* Patient has BMI \\> 40\n* Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator\n* 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\n* Female patients pregnant at the time of the surgical procedure.\n* Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)\n* Patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study\n* Patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia'}, 'identificationModule': {'nctId': 'NCT06445504', 'briefTitle': 'Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'MDT21022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic-Assisted Surgery (RAS) Hernia Repair Surgery', 'description': 'Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system', 'interventionNames': ['Device: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery']}], 'interventions': [{'name': 'Robotic-Assisted Surgery (RAS) Hernia Repair Surgery', 'type': 'DEVICE', 'description': 'Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system', 'armGroupLabels': ['Robotic-Assisted Surgery (RAS) Hernia Repair Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '14260', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77401', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}], 'overallOfficials': [{'name': 'Jacob Greenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}