Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-11 @ 6:51 AM
Study NCT ID:
NCT04171102
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neo-nervegenesis in Inguinal Hernia Implant ProFlor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amatomed@gmail.com', 'phone': '337963197', 'title': 'Prof. Dr. Giuseppe Amato', 'organization': 'University of Cagliari'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'All participant underwent biopsy from the implanted prosthesis. Being the prosthesis positioned in the inguinal area outside of the abdominal cavity, this minimally invasive procedure produces no risks of mortality. Also risks for serious adverse events are nullified because the tissue removal do not involve any vital organs', 'eventGroups': [{'id': 'EG000', 'title': 'Short Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mid Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Long Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Term Post Implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post implantation'}, {'id': 'OG001', 'title': 'Mid Term Post Implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post implantation'}, {'id': 'OG002', 'title': 'Long Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '999.75', 'spread': '113.32', 'groupId': 'OG000'}, {'value': '1044', 'spread': '695.95', 'groupId': 'OG001'}, {'value': '2094', 'spread': '490.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': '\\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 weeks until 8 months post-implantation', 'description': 'Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation', 'unitOfMeasure': 'μm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who underwent inguinal hernia repair with ProFlor'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neonervegenesis in ProFlor Hernia Implant in the Short Term', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation'}, {'id': 'FG001', 'title': 'Neonervegenesis in ProFlor Hernia Implant in the Mid Term', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation'}, {'id': 'FG002', 'title': 'Neonervegenesis in ProFlor Hernia Implant in the Long Term', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Short Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation'}, {'id': 'BG001', 'title': 'Mid Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation'}, {'id': 'BG002', 'title': 'Long Term Post-implantation', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '4561', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '4871', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '4881', 'groupId': 'BG002'}, {'value': '58.23', 'spread': '4581', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Inguinal hernia patients operated with ProFlor who needed further surgery in the previously operated groin for various pathologies'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2019-11-15', 'resultsFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-26', 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor', 'timeFrame': '3 weeks until 8 months post-implantation', 'description': 'Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hernia implants', 'Biologic response', 'Neo-nervegenesis', 'Regenerative scaffold'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '21752035', 'type': 'BACKGROUND', 'citation': 'Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.'}, {'pmid': '25626584', 'type': 'BACKGROUND', 'citation': 'Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.'}, {'pmid': '30318605', 'type': 'BACKGROUND', 'citation': 'Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.'}, {'pmid': '32169570', 'type': 'RESULT', 'citation': 'Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.', 'detailedDescription': 'Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor\n* Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor\n* Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor\n\nExclusion Criteria:\n\n* Patients who underwent inguinal hernia repair with conventional flat meshes'}, 'identificationModule': {'nctId': 'NCT04171102', 'briefTitle': 'Neo-nervegenesis in Inguinal Hernia Implant ProFlor', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor', 'orgStudyIdInfo': {'id': 'Neo-nervegenesis in ProFlor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short term post inguinal hernia repair wit ProFlor', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation', 'interventionNames': ['Device: ProFlor Hernia implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mid term post inguinal hernia repair wit ProFlor', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation', 'interventionNames': ['Device: ProFlor Hernia implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long term post inguinal hernia repair wit ProFlor', 'description': 'Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation', 'interventionNames': ['Device: ProFlor Hernia implant']}], 'interventions': [{'name': 'ProFlor Hernia implant', 'type': 'DEVICE', 'description': 'Inguinal hernia repair', 'armGroupLabels': ['Long term post inguinal hernia repair wit ProFlor', 'Mid term post inguinal hernia repair wit ProFlor', 'Short term post inguinal hernia repair wit ProFlor']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giuseppe Amato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cagliari'}]}, 'ipdSharingStatementModule': {'timeFrame': 'from actual date until december 2021', 'ipdSharing': 'YES', 'description': 'Tissue specimen and histological records upon request', 'accessCriteria': 'personal contact'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Professor', 'investigatorFullName': 'Giuseppe Amato', 'investigatorAffiliation': 'University of Cagliari'}}}}