Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT05379751
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Repair of Spigelian Hernia in a Cohort of Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A cohort of 54 patients diagnosed with Spigelian hernia who underwent open surgical repair with the tentacle shaped implant (Freedom Octomesh VHR XS produced by Insightra Medical Inc. - USA) forms the body of this study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-12', 'studyFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fixation free prosthetic repair of Spigelian hernias with tentacle mesh', 'timeFrame': 'Intraoperative', 'description': 'Feasibility of fixation free placement of tentacle mesh in Spigelian hernia repair'}, {'measure': 'Granting a broad implant overlap in prosthetic repair of Spigelian hernias with tentacle mesh', 'timeFrame': 'between 6 and 84 months postop', 'description': 'Granting a broad overlap over the hernial defect after placement in preperitoneal sublay of tentacle mesh in Spigelian hernia repair with tentacle mesh to reduce risks of recurrence in the long term postop.'}], 'secondaryOutcomes': [{'measure': 'Intra-operative features', 'timeFrame': 'intraoperatively', 'description': 'reduction of the operative time length'}, {'measure': 'Postoperative features 1', 'timeFrame': 'between 6 and 84 months postop', 'description': 'Postoperative pain assessment with VAS scoring system'}, {'measure': 'Postoperative features 2', 'timeFrame': 'between 6 and 84 months postop', 'description': 'Assessment of postoperative complications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spigelian Hernia']}, 'descriptionModule': {'briefSummary': 'Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure', 'detailedDescription': 'The surgical treatment of Spigelian hernias is mainly carried out with prosthetic meshes made of biocompatible material. In prosthetic repair of abdominal protrusions, mesh fixation and overlap of the mesh are source of complications. To avoid these problems, for a fixation free repair of Spigelian hernias has been developed a tentacle shaped implant, that should also assure a broader defect overlap. This study should highlight in a cohort of patients the long-term results of fixation free repair of Spigelian hernias carried out with tentacle mesh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with Spigelian hernia\n\nExclusion Criteria:\n\n* Patients not having Spigelian hernia,'}, 'identificationModule': {'nctId': 'NCT05379751', 'briefTitle': 'Surgical Repair of Spigelian Hernia in a Cohort of Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair', 'orgStudyIdInfo': {'id': 'Spigelian hernia treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh', 'description': 'Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS', 'interventionNames': ['Procedure: Fixation free Spigelian hernia repair with tentacle mesh']}], 'interventions': [{'name': 'Fixation free Spigelian hernia repair with tentacle mesh', 'type': 'PROCEDURE', 'description': 'Spigelian hernias are repaired through the fixation free placement of a tentacle mesh in preperitoneal sublay thanks the friction exerted by the tentacle straps delivered by a proprietary needle passer crossing trouh the abdominal wall from the preperitoneal space until the subutaneous layer. This procedural approach should also grant a broad overlap of the implant over the hernial defect', 'armGroupLabels': ['Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Professor', 'investigatorFullName': 'Giuseppe Amato', 'investigatorAffiliation': 'University of Cagliari'}}}}