Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT07267533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precise 3D Surview
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 274}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance rate of the 3D Surview', 'timeFrame': 'Reading session at 4 months'}]}, 'conditionsModule': {'conditions': ['Computed Tomography']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the performance of Precise 3D Surview on CT 5300 and Incisive CT Scanners as compared with manual annotation by experienced CT technologists.\n\n* To evaluate the acceptance rate of the Auto 3D Planning Box compared with manual annotation by experienced CT technologists.\n* To evaluate the acceptance rate of the Auto Suggestion for Locator compared with manual annotation by experienced CT technologists.\n* To evaluate the acceptance rate of the Auto Planning for Truncated Anatomies (lung and liver) compared with manual annotation by experienced CT technologists.\n* To evaluate the acceptance rate of Auto Planning and Symmetry Correction for Tilted Head compared with manual annotation by experienced CT technologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects scanned by CT 5300 (K232491) and Incisive CT (K212441) according to the department standard of care clinical protocols.\n* Subjects age is over eighteen (18) years1.\n* Patients scanned in supine orientation.\n* Non-contrast CT scan\n* CT scan with standard resolution\n\nExclusion Criteria:\n\n* Subjects age is under or equal 18 years old\n* Patients are not scanned in supine orientation.\n* Contrast-enhanced CT scans.\n* CT scans with high resolution\n* Scans that are not completed due to technical difficulties'}, 'identificationModule': {'nctId': 'NCT07267533', 'acronym': '3D Surview', 'briefTitle': 'Precise 3D Surview', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Precise 3D Surview Clinical Study', 'orgStudyIdInfo': {'id': 'Precise 3D Surview'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Philips Healthcare (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}