Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-11 @ 11:53 AM
Study NCT ID:
NCT02217150
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The STAR Prospective Clinical Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-13', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': '1 month', 'description': 'Mean change from baseline in worst pain score per NRPS at one month'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': '3 months', 'description': 'Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)'}, {'measure': 'Change if Quality of Life', 'timeFrame': '3 months', 'description': 'Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)'}, {'measure': 'Change in Function', 'timeFrame': '3 months', 'description': 'Change from baseline at each visit using Modified Oswestry Disability Index (MODI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastasis to Vertebral Column']}, 'descriptionModule': {'briefSummary': 'Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.\n\nExclusion Criteria:\n\n* The device is contraindicated in subjects with heart pacemakers, or other electronic device implants.\n* The device is contraindicated in vertebral body levels C1-7.'}, 'identificationModule': {'nctId': 'NCT02217150', 'acronym': 'PCS', 'briefTitle': 'The STAR Prospective Clinical Series', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'The DFINE STAR™ Tumor Ablation Prospective Clinical Series', 'orgStudyIdInfo': {'id': 'PCS'}, 'secondaryIdInfos': [{'id': '20130370', 'type': 'OTHER', 'domain': 'WIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metastatic Lesions to the spine', 'description': 'Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92027', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Palomar Pomerado Health System', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Suburban Hospital', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Radiological Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Alexandria Hospital', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Hospital', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Sandeep Bagla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Alexandria Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DFINE Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}