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AI-Based Analysis of Port Catheter Tip Position

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion moved earlier from Jan 2027 to Nov 2026
    • Study completion moved earlier from Feb 2027 to Nov 2026
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 20 of 20 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective, single-center observational study will evaluate the performance of an artificial intelligence (AI)-based automated image-analysis method that will be developed, internally tested, and locked before prospective enrollment. The method will estimate the position of totally implantable venous access port catheter tips in adults undergoing right internal jugular vein port implantation as part of routine care. The automated estimate will be compared with a prespecified manual measurement method. Reference measurements of the catheter tip and the cavoatrial junction will be obtained from clinically indicated chest computed tomography images when both structures are visible. No additional chest radiography or computed tomography will be performed for research purposes, and the automated output will not guide catheter placement or alter clinical decisions. The primary performance measure will be the mean absolute error of the automated estimate in the prospective cohort.
Trial Details
NCT Number NCT07791875
Lead Sponsor Bagcilar Training and Research Hospital
Conditions
(from sponsor)		 Vascular Access Devices
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov