Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT02419703
Status:
TERMINATED
Last Update Posted:
2017-04-12
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The STAR™ Tumor Ablation Registry
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': 65}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Difficulty Enrolling', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief (Numerical Rating Pain Scale), post t-RFA', 'timeFrame': '1 month', 'description': 'measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)'}], 'secondaryOutcomes': [{'measure': 'Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)', 'timeFrame': '1 week, 1 month, 3 month, 6 month, 12 month', 'description': 'measured by the FACT G7 \\& Numerical Rating Pain Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Lesions in Vertebral Bodies']}, 'descriptionModule': {'briefSummary': 'Registry collecting data on use of The STAR™ Tumor Ablation System.', 'detailedDescription': 'The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.\n* Have signed informed consent\n\nExclusion Criteria:\n\n* Subjects under 18 years old\n* Subjects with heart pacemakers, or other electronic device implants\n* Subjects intended for t-RFA in vertebral body levels C1-7'}, 'identificationModule': {'nctId': 'NCT02419703', 'briefTitle': 'The STAR™ Tumor Ablation Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'The STAR™ Tumor Ablation Registry', 'orgStudyIdInfo': {'id': 'DF-15-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving Targeted Radiofrequency Ablation (t-RFA)', 'interventionNames': ['Device: STAR™ Tumor Ablation System']}], 'interventions': [{'name': 'STAR™ Tumor Ablation System', 'type': 'DEVICE', 'description': 'Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.', 'armGroupLabels': ['Patients receiving Targeted Radiofrequency Ablation (t-RFA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Medical Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Institute of Neurological Surgery', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': "St. Joseph's Medical Center", 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mori Bean and Brook Radiology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Imaging & Therapeutics', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'VIR Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'DFINE Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}