Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04541316
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2020-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neo-angiogenesis in Inguinal Henia Implant ProFlor
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal hernia repair'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor', 'timeFrame': '3-5 weeks post-implantation', 'description': 'Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation'}, {'measure': 'Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor', 'timeFrame': '3-4 months post implantation', 'description': 'Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation'}, {'measure': 'Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor', 'timeFrame': '6-8 months post implantation', 'description': 'Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hernia implants', 'Biologic response', 'Neo-angiogenesis', 'Regenerative scaffolds'], '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': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://studio.youtube.com/channel/UCY7k5T6N3WtVqfTnitfTEfg/videos/upload?filter=%5B%5D&sort=%7B%22columnType%22%3A%22date%22%2C%22sortOrder%22%3A%22DESCENDING%22%7D', 'label': 'ProFlor inguinal hernia repair: features, procedural steps and clinical data'}]}, 'descriptionModule': {'briefSummary': 'The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, 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 vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing 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': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor\n* Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor\n* Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor\n\nExclusion Criteria:\n\n* immunosoppressive therapy, \\> ASA 4 classification'}, 'identificationModule': {'nctId': 'NCT04541316', 'briefTitle': 'Neo-angiogenesis in Inguinal Henia Implant ProFlor', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor', 'orgStudyIdInfo': {'id': 'Neo-angiogenesis in ProFlor'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short term post inguinal hernia repair with ProFlor', 'description': 'Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-5 weeks post implantation', 'interventionNames': ['Device: ProFlor inguinal hernia device']}, {'label': 'Mid term post inguinal hernia repair with ProFlor', 'description': 'Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-4 months post implantation', 'interventionNames': ['Device: ProFlor inguinal hernia device']}, {'label': 'Long term post inguinal hernia repair with ProFlor', 'description': 'Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 6-8 months post implantation', 'interventionNames': ['Device: ProFlor inguinal hernia device']}], 'interventions': [{'name': 'ProFlor inguinal hernia device', 'type': 'DEVICE', 'description': 'Inguinal hernia repair', 'armGroupLabels': ['Long term post inguinal hernia repair with ProFlor', 'Mid term post inguinal hernia repair with ProFlor', 'Short term post inguinal hernia repair with ProFlor']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giuseppe Amato', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cagliari'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'from actual date until December 2022', 'ipdSharing': 'YES', 'description': 'Tissue specimen and histological records upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Professor', 'investigatorFullName': 'Giuseppe Amato', 'investigatorAffiliation': 'University of Cagliari'}}}}