Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-27 @ 6:58 PM
Study NCT ID:
NCT06042205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2023-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Device Effect (SADEs)', 'timeFrame': 'through 12 months post-surgery', 'description': 'Cumulative incidence of complications (CIC) related to the TAHRS including:\n\nInfection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,'}], 'secondaryOutcomes': [{'measure': 'Rate of hernia recurrence through 12 months post- surgery', 'timeFrame': 'through 12 months post-surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hernia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subject is 18 years old or older;\n2. Patient willing and able to provide a signed Patient Informed Consent Form;\n3. Has a midline primary ventral, umbilical or incisional hernia;\n4. Scheduled for a laparoscopic IPOM hernia repair;\n5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect\n\nKey Exclusion Criteria:\n\n1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);\n2. BMI \\> 40;\n3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;\n4. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;\n5. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;\n6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;\n7. Patient has more than one hernia defect (to be confirmed intraoperatively);'}, 'identificationModule': {'nctId': 'NCT06042205', 'briefTitle': 'TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tissium'}, 'officialTitle': 'ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair', 'orgStudyIdInfo': {'id': 'PF00006-CLPR-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hernia repair', 'description': 'There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Atraumatic Hernia Repair System (TAHRS)', 'interventionNames': ['Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)']}], 'interventions': [{'name': 'TISSIUM™ Atraumatic Hernia Repair System (TAHRS)', 'type': 'DEVICE', 'description': 'The TAHRS is intended for fixation of prosthetic material to soft tissue', 'armGroupLabels': ['Hernia repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg [ZOL]', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Hospital', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Ruddershove', 'country': 'Belgium', 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 50.88235, 'lon': 3.7606}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'CHU UCL Namur', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Universitary Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tissium', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}