Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-17 @ 7:09 PM
Study NCT ID:
NCT01816867
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate at 12 months determined by clinical examination', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Intraoperative complications', 'timeFrame': 'peri-procedural', 'description': 'Defined as complications occurring during index-procedure from "skin-into-skin". The following events must be reported in the case report form:\n\n* enterotomy (bowel injury)\n* major bleeding requiring blood transfusion or reintervention\n* complications due to anesthesia\n* minor bleeding at a trocar insertion site'}, {'measure': 'Post-operative complications', 'timeFrame': 'up to 30 days', 'description': 'Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form:\n\n* local numbness\n* hematoma\n* seroma\n* superficial trocar site infection\n* mesh infection\n* hernia recurrence\n* death'}, {'measure': 'Seroma', 'timeFrame': '1 month', 'description': 'The rate of seroma at 1 month after index-procedure.'}, {'measure': 'Freedom from hernia-related reinterventions', 'timeFrame': '12 months', 'description': 'Reinterventions at 12 months after index-procedure'}, {'measure': 'Late complications', 'timeFrame': '12 months', 'description': 'Late complications at 12 months after index-procedure:\n\n* prolonged pain more than 8 weeks\n* local numbness\n* hernia recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hernia', 'Treatment', 'laparoscopic', 'open technique'], 'conditions': ['Ventral Hernia']}, 'referencesModule': {'references': [{'pmid': '28438090', 'type': 'DERIVED', 'citation': 'Wen W, Majerus B, Van De Moortel M, Lobue S, Fobe D, Philippart P, Berwouts L, Coteur J, Gabriels K, Van der Speeten K. Laparoscopic ventral hernia repair using a composite mesh with polypropylene and expanded polytetrafluoroethylene: a prospective, multicentre registry. Acta Chir Belg. 2017 Oct;117(5):295-302. doi: 10.1080/00015458.2017.1313526. Epub 2017 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a ventral hernia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is older than 18 years\n* Written informed consent is obtained from patient\n* Patient with a primary or incisional ventral hernia\n\nExclusion Criteria:\n\n* Patient with a recurrent ventral hernia\n* Patient with ASA class 5 and 6\n* Patient underwent emergency surgery\n* Patient is pregnant\n* Patient with a known allergy to components of the ePTFE prosthesis\n* Patient has a life expectancy less than 1 year\n* Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors'}, 'identificationModule': {'nctId': 'NCT01816867', 'briefTitle': 'Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1', 'organization': {'class': 'INDUSTRY', 'fullName': 'be Medical'}, 'officialTitle': 'Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry', 'orgStudyIdInfo': {'id': 'BM-T1-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a ventral hernia', 'interventionNames': ['Device: Intramesh T1 implantation']}], 'interventions': [{'name': 'Intramesh T1 implantation', 'type': 'DEVICE', 'otherNames': ['Intramesh T1 Cousin Biotech'], 'armGroupLabels': ['Patients with a ventral hernia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Kurt Van der Speeten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'be Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}