Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 5:12 PM
Study NCT ID:
NCT01957904
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2013-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ArterX Safety and Efficacy Study for Cardiac Indications
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': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2013-09-27', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with immediate sealing of suture/staple line', 'timeFrame': 'during surgery', 'description': 'Immediate sealing of the suture/staple line at point of use upon release of the clamps, as evidenced by an absence of clinically significant bleeding as determined by physician investigator in procedures completed using the ArterX device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ArterX, surgical sealant'], 'conditions': ['Vascular Disease']}, 'referencesModule': {'references': [{'pmid': '25810290', 'type': 'RESULT', 'citation': 'Skorpil J, Paraforos A, Mandak J, Cohn WE, Hajek T, Friedrich I. Effective and rapid sealing of coronary, aortic and atrial suture lines dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):720-4; discussion 724. doi: 10.1093/icvts/ivv061. Epub 2015 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.\n\nThe subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.\n\nThe subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.\n\nThe subject is determined by the surgeon to be at risk for poor hemostasis.\n\nExclusion Criteria:\n\nSubject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.\n\nSubject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.\n\nSubject is pregnant, may become pregnant or is currently breast feeding\n\n\\-"}, 'identificationModule': {'nctId': 'NCT01957904', 'briefTitle': 'ArterX Safety and Efficacy Study for Cardiac Indications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tenaxis Medical, Inc.'}, 'officialTitle': 'Prospective, Multi-Center, Open-Label, Post-Market ArterX® Safety and Efficacy Study Protocol for Cardiac Indications', 'orgStudyIdInfo': {'id': 'CLN-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ArterX Surgical Sealant', 'interventionNames': ['Device: ArterX Surgical Sealant']}], 'interventions': [{'name': 'ArterX Surgical Sealant', 'type': 'DEVICE', 'armGroupLabels': ['ArterX Surgical Sealant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trier', 'country': 'Germany', 'facility': 'Krankenhaus Der Barmherzigen Bruder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tenaxis Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}