Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT03374735
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2017-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elapsed time from clamp release to hemostasis at the suture line', 'timeFrame': 'During surgical procedure', 'description': 'The hemostasis is observed by the operating surgeon and timed by an operative room nurse.\n\nAnastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding.'}, {'measure': 'All adverse events occurring from the surgical procedure to Week 12', 'timeFrame': 'Week 12', 'description': 'Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old;\n* Surgical placement of an ePTFE patch for large carotid repair;\n* Written informed consent given by the patient.\n\nExclusion Criteria:\n\n* Known or suspected allergy or sensitivity to any test materials or reagents;\n* Concomitant intake of immunosuppressive medications;\n* Prior radiation therapy to the operating field;\n* Previous surgical procedure performed on the same operating field;\n* Current or recent (\\<3months) participation in another investigational study;\n* Refusal to receive blood products;\n* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT03374735', 'briefTitle': 'First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gecko Biomedical'}, 'officialTitle': 'Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.', 'orgStudyIdInfo': {'id': 'GB02-CL-1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SETALUM™ Sealant', 'description': 'SETALUM™ Sealant to be applied on the suture line', 'interventionNames': ['Device: SETALUM™ Sealant']}], 'interventions': [{'name': 'SETALUM™ Sealant', 'type': 'DEVICE', 'description': 'SETALUM™ Sealant to be applied on the suture line', 'armGroupLabels': ['SETALUM™ Sealant']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gecko Biomedical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}