Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT03667235
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005976', 'term': 'Glutaral'}], 'ancestors': [{'id': 'D000447', 'term': 'Aldehydes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets) will be fixed in glutaraldehyde in the operation room and stored in sterile tubes in Phosphate Buffered Saline(PBS) and transferred at room temperature to the lab where it will be stored in a lab fridge at 4°C.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mechanic stability tests to investigate uniaxial and cyclical tensile properties', 'timeFrame': '4 days after surgery', 'description': 'mechanical tests include the use of a universal test machine (MTS Bionix, Department of Bioengineering of Universitaetsspital Basel) for:\n\n* uniaxial ultimate tensile strength (UTS) test;\n* cyclical tensile stretching of the tissue in order to investigate its viscoelastic properties'}, {'measure': 'thermic stability by using constant force at linearly increasing temperature', 'timeFrame': '4 days after surgery', 'description': 'constant force at linearly increasing temperature: Thermal stability tests will be conducted on 20 x 4 mm stripes by the imposition of a constant load (approximately 1N) submerged in a saline-solution bath. The temperature of the bath will be increased at a rate of approximately 2.5-5 °C/min, and the sample cross-section will be measured by means of a high-resolution camera (Canon EOS, Japan)'}], 'secondaryOutcomes': [{'measure': 'histologic analysis of collagen fiber organization and quantification', 'timeFrame': '4 days after surgery', 'description': 'histologic analysis by Scanning Electrical Microscopy (SEM) and using Picrosirius staining to identify the types I and IV collagen'}, {'measure': 'Pronase testing to analyse enzymatic degradation', 'timeFrame': '4 days after surgery', 'description': 'Pronase testing to analyse enzymatic degradation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OZAKI technique'], 'conditions': ['Aortic Valve Surgery']}, 'descriptionModule': {'briefSummary': 'To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes', 'detailedDescription': 'Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).\n\nThis study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.\n\nTo investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)\n\nExclusion Criteria:\n\n* denial of consent\n* insufficient leftover tissues from the OZAKI procedure\n* patients after thoracic radiation or surgery'}, 'identificationModule': {'nctId': 'NCT03667235', 'acronym': '10vs20-OZAKI', 'briefTitle': '10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': '10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure', 'orgStudyIdInfo': {'id': '2017-01334; ch17Reuthebuch2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment of human pericardium with glutaraldehyde in OZAKI procedure', 'type': 'OTHER', 'description': '10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure'}, {'name': 'Treatment of human aortic valve tissue with glutaraldehyde', 'type': 'OTHER', 'description': '10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Herzchirurgie University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Oliver Reuthebuch, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}