Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT04764760
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients with confirmed inguinal hernias of all types'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1987-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence free outcome', 'timeFrame': '5 years', 'description': 'The prospective study of 486 patients includes implantation of the specially designed Tensiflex mesh prosthesis in117 patients for seamless augmentation of the tensile strength,has rendered 100% recurrence free oucomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tensile strength augmentation.'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': '"A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis."', 'detailedDescription': "Hernia recurrences post-repair remain a confounding problem. The prospective study described herein tested Cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall resistance causes hernia, by incorporating the Tensiflex mesh prosthesis which is a modified version of mesh prosthesis of Stoppa technique in the surgical treatment of patients with hernia. The study was 2-phased: the first phase involved the pre-peritoneal implantation of a bi-layered mesh for anatomical replacement of the damaged fascia. The second phase involved the implantation of the bi-layered Tensiflex mesh prosthesis for definitive and seamless augmentation of tensile strength in the myopectineal orifice of Fruchaud.\n\nEighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on day 3); however, by day 5, 86% reported pain intensity scores lower than 5. The median number of lost workdays was 7. Most importantly, the primary endpoint of 100% recurrence-free outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of workdays)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with confirmed groin hernia of both sexes.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04764760', 'briefTitle': 'Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'St. Joseph Mercy Oakland Hospital'}, 'officialTitle': 'Former Chairman Department of Surgery St.Joseph Mercy Oakland Pontiac Former Clinical Associate Professor Surgery Wayne State University,Detroit', 'orgStudyIdInfo': {'id': 'StJosephMOH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Phase 1:Study role tissue tensile strength', 'description': 'The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.', 'interventionNames': ['Device: Wing shaped Tensiflex prosthesis']}, {'type': 'OTHER', 'label': 'Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis', 'description': 'The wing shaped custom designed tensiflex prosthesis in the groin was impanted as a curative technique since it provided seamless augmenation of the tensile tissue strength.', 'interventionNames': ['Device: Wing shaped Tensiflex prosthesis']}], 'interventions': [{'name': 'Wing shaped Tensiflex prosthesis', 'type': 'DEVICE', 'description': 'Curative inguinal hernia repair techniqque', 'armGroupLabels': ['Phase 1:Study role tissue tensile strength', 'Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48341', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'St.Joseph Mercy Oakland Pontiac', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}], 'overallOfficials': [{'name': 'Narendra Tyagi, MD FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St.Joseph Mercy Oakland Pontiac'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Starting immediately after publication', 'ipdSharing': 'YES', 'description': 'All collected IPD', 'accessCriteria': 'All surgeons'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Joseph Mercy Oakland Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Former Chairman of surgery St. Joseph Mercy Oakland Hospital', 'investigatorFullName': 'Narendra Tyagi MD', 'investigatorAffiliation': 'St. Joseph Mercy Oakland Hospital'}}}}