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RECRUITING
NCT07858162

Prospective Silent Evaluation of AI for Retained Foreign Object Detection

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Retained foreign objects, such as surgical sponges, needles, or instruments, are rare but potentially serious complications of surgery. When there is concern that an object may have been left behind, an intraoperative radiograph may be obtained while the patient is still in the operating room. These radiographs can be difficult to interpret because of overlapping surgical equipment, patient positioning, and the need for rapid interpretation. This prospective observational study evaluates an artificial intelligence (AI) system designed to detect retained foreign objects on intraoperative radiographs. Eligible radiographs obtained during routine clinical care will be automatically processed by the AI system in real time for approximately one year. The AI results will not be shown to radiologists, surgeons, or other members of the clinical care team and will not affect patient care. The study will evaluate how accurately the AI system detects retained foreign objects and how reliably and quickly the system operates in a real-world clinical environment.

Official title: Prospective Silent Evaluation of a Real-Time Artificial Intelligence System for Detection of Retained Foreign Objects on Intraoperative Radiographs

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-02-01

Completion Date

2027-02-01

Last Updated

2026-10-05

Healthy Volunteers

No

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States