Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT01751958
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Exposure in Spine Intervention Under Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose', 'timeFrame': 'Treatment on the day', 'description': 'Radiation dose of patients with spine invervention under angiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI', 'detailedDescription': 'The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected of having radiculopathic low back pain\n\nExclusion Criteria:\n\n* Angiography is contraindicated'}, 'identificationModule': {'nctId': 'NCT01751958', 'briefTitle': 'Radiation Exposure in Spine Intervention Under Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI', 'orgStudyIdInfo': {'id': 'B-1105/128-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural Steroid injection', 'description': 'Group-Epidural Steroid injection (Intermittent)', 'interventionNames': ['Radiation: Epidural steroid injection']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural Steroid Injection2', 'description': 'Group-injection under angiography (continuous)', 'interventionNames': ['Radiation: Epidural steroid injection']}], 'interventions': [{'name': 'Epidural steroid injection', 'type': 'RADIATION', 'description': 'Epidural steroid injection', 'armGroupLabels': ['Epidural Steroid Injection2', 'Epidural Steroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Joon-woo Lee', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Joon-woo Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Suyoung Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}