Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 2:06 PM
Study NCT ID:
NCT06665360
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identify the State of Laminae Milling by Sound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of sound pressure', 'timeFrame': 'The sound pressure signals were collected during the operation in 6 cases, an average of 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Degenerative Diseases']}, 'descriptionModule': {'briefSummary': 'After verifying the signals collected in the laboratory, the investigators performed a preliminary verification in the surgery, in which the sound pressure signals of lamina milling were collected during the surgery to identify milling status.', 'detailedDescription': 'The sound of milling cortical bone and cancellous bone were recorded during posterior spinal decompression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with spinal stenosis requiring surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with myelopathy caused by spinal stenosis who had undergone posterior decompression.\n\nExclusion Criteria:\n\n1. Receipt of surgery using an anterior approach or circumferential spinal cord decompression through a posterior approach;\n2. Experience of trauma;\n3. History of spinal tumor;\n4. Previous spinal surgery;'}, 'identificationModule': {'nctId': 'NCT06665360', 'briefTitle': 'Identify the State of Laminae Milling by Sound', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Sound Timbre-based Milling Status Identification in Robotic Vertebral Lamina Milling', 'orgStudyIdInfo': {'id': 'IRB2021-KY-198'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'posterior spinal decompression', 'interventionNames': ['Other: The high speed bur was used to mill the cancellous cortical bone of the lamina']}], 'interventions': [{'name': 'The high speed bur was used to mill the cancellous cortical bone of the lamina', 'type': 'OTHER', 'description': 'The high speed bur was used to mill the cancellous cortical bone of the lamina', 'armGroupLabels': ['posterior spinal decompression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nankai University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Candidate', 'investigatorFullName': 'Rui Wang', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}