Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04753905
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of surgical guile', 'timeFrame': '1 year', 'description': "To evaluate the accuracy of surgical guide, we use the image during surgery to determine whether it's accurate."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with scoliosis and the cobb angle exceeds over 50 degree.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scoliosis patients\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04753905', 'briefTitle': 'Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery', 'orgStudyIdInfo': {'id': 'V110C-099'}}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Teipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}