Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 9:52 AM
Study NCT ID:
NCT07317427
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Image for Interventional CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, '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': '2025-12-18', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale', 'timeFrame': 'Reading session at 4 months', 'description': 'The image quality of Precise Image reconstructions is non-inferior to iDose4 reconstructions for interventional CT images of adult patients. Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.'}]}, 'conditionsModule': {'conditions': ['Computed Tomography']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (\\>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image.\n\nThe study has two objectives:\n\n1. To evaluate the image quality for procedural guidance and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for:\n\n * Interventional CT images of adult patients (\\>18 years old).\n2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.'}, '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 FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable clinical scans.\n* Subject age: \\>18 years old.\n* Presence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.\n\nExclusion Criteria:\n\n* Subject age: 18 years old and below.\n* Absence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.\n* Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).\n* Scans that the site interventional radiologists have deemed non-suitable for procedural guidance.'}, 'identificationModule': {'nctId': 'NCT07317427', 'briefTitle': 'Precise Image for Interventional CT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Clinical Study for Precise Image for Interventional CT for Incisive CT and CT 5300 Systems', 'orgStudyIdInfo': {'id': 'Precise Image for CCT'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Philips Healthcare (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}