Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT03021720
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'From date of procedure to one month after procedure', 'description': 'Based on visual analog scale (min 0, max 10; higher score indicates better outcome)'}], 'secondaryOutcomes': [{'measure': 'Procedure related complication rate', 'timeFrame': 'Up to one month after procedure', 'description': 'Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline'}, {'measure': 'Procedure time', 'timeFrame': 'Duration of intra-procedural time', 'description': 'Procedure time'}, {'measure': 'Fluoroscopy Time', 'timeFrame': 'Duration of intra-procedural fluoroscopy', 'description': 'Fluoroscopy time used during the procedure'}, {'measure': 'Procedure equipment cost', 'timeFrame': 'Procedure', 'description': 'Cost of disposable equipment used for the procedure'}, {'measure': 'Health related quality of life', 'timeFrame': '1 month post procedure', 'description': 'Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine fibroid embolization', 'Uterine artery embolization', 'Arterial access', 'Radial access', 'Interventional radiology', 'Quality of life', 'Patient Satisfaction', 'Patient centered care', 'Uterine fibroid'], 'conditions': ['Uterine Fibroid']}, 'descriptionModule': {'briefSummary': 'Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access', 'detailedDescription': '1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting standard eligibility criteria for uterine fibroid embolization\n* Satisfactory ulnopalmar arch patency\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable or unwilling to complete the study questionnaires\n* Failed Barbeau test'}, 'identificationModule': {'nctId': 'NCT03021720', 'acronym': 'SPARQLE', 'briefTitle': 'Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial', 'orgStudyIdInfo': {'id': '16-0227-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral arterial access', 'description': 'Femoral arterial puncture for the uterine fibroid embolization procedure', 'interventionNames': ['Procedure: Arterial access']}, {'type': 'EXPERIMENTAL', 'label': 'Radial arterial access', 'description': 'Radial arterial puncture for the uterine fibroid embolization procedure', 'interventionNames': ['Procedure: Arterial access']}], 'interventions': [{'name': 'Arterial access', 'type': 'PROCEDURE', 'description': 'Location of arterial puncture', 'armGroupLabels': ['Femoral arterial access', 'Radial arterial access']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'John Kachura', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, University Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Radiologist; Associate Professor of Medical Imaging', 'investigatorFullName': 'John Kachura', 'investigatorAffiliation': 'Mount Sinai Hospital, Canada'}}}}