Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02969005
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The times of C-arm fluoroscopy used', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'incision length', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiopaque localizer grid', 'methylene blue', 'reduce radiation exposure'], 'conditions': ['Bone Diseases']}, 'descriptionModule': {'briefSummary': 'Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.', 'detailedDescription': "This study was performed to evaluate the use of a radiopaque localizer grid along with methylene blue staining for resection of small femur lesions in children, and to determine this technique's effectiveness at reducing radiation exposure and tissue injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with lesions \\<20.0 mm\n\nExclusion Criteria:\n\n* patients with lesions \\>20.0 mm'}, 'identificationModule': {'nctId': 'NCT02969005', 'briefTitle': 'Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': 'Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions', 'orgStudyIdInfo': {'id': 'ChongqingMUCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery group', 'description': 'The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.', 'interventionNames': ['Radiation: surgical treatment']}], 'interventions': [{'name': 'surgical treatment', 'type': 'RADIATION', 'description': 'Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions', 'armGroupLabels': ['surgery group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Guoxin Nan', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}