Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT05017233
Status:
TERMINATED
Last Update Posted:
2024-05-17
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectral CT Clinical Trial Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excellent and good rate of clinical imaging (score≥3）', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory'}], 'secondaryOutcomes': [{'measure': 'Common functions assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied'}, {'measure': 'Convenience evaluation assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied'}, {'measure': 'Machine function and stability assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied'}, {'measure': 'Adverse events and serious adverse events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['CT Scanning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT', 'detailedDescription': 'Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recruit volunteers (ages 18 to 75);\n* Negative pregnancy tests in women of childbearing age;\n* Participants who agree to participate in this clinical trial and sign the informed consent;\n* Enhanced scans require laboratory tests to confirm normal renal function.\n\nExclusion Criteria:\n\n* Persons who do not have full capacity for civil conduct;\n* Lactating women;\n* People who are not suitable for enhanced scanning with iodine contrast agent;\n* Patients whom the investigator considers inappropriate to participate in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT05017233', 'briefTitle': 'Spectral CT Clinical Trial Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips (China) Investment CO., LTD'}, 'officialTitle': 'Spectral CT Clinical Trial Protocol', 'orgStudyIdInfo': {'id': 'PD_CT_Hawk_2021_11258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group, all volunteer will be scanned.', 'description': 'All participation accept Spectral CT scanning; No group;', 'interventionNames': ['Device: Spectral CT']}], 'interventions': [{'name': 'Spectral CT', 'type': 'DEVICE', 'description': 'Using Spectral CT to scan Breast', 'armGroupLabels': ['Experimental group, all volunteer will be scanned.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shiyuan Liu, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospital'}, {'name': 'Fuhua Yan, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Bin Song, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips (China) Investment CO., LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}