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AI-Based Analysis of Port Catheter Tip Position

NCT07791875 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Vascular Access Devices

Interventions

DIAGNOSTIC_TEST

AI-Based Automated Image Analysis

The locked automated method will use chest radiographic image analysis and a patient-specific Delta adjustment to estimate port catheter tip position. The method will be evaluated offline using reference measurements derived from clinically indicated post-implantation noncontrast chest computed tomography. Its output will not be provided to the clinical team and will not guide port implantation or alter clinical decisions.

DIAGNOSTIC_TEST

Manual A+B Measurement Method

The prespecified manual A+B method will estimate port catheter tip position using surface and chest radiographic measurements. It will be applied as a comparator in the same participants. The manual research measurement will not guide port implantation or alter clinical care.

Sponsors & Collaborators

  • Bagcilar Training and Research Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-05
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791875 on ClinicalTrials.gov