Prospective Silent Evaluation of AI for Retained Foreign Object Detection

Conditions

• Retained Foreign Object

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Oct 5, 2026

Start date

Feb 1, 2026

Status verified

Sep 2026

Primary completion

Feb 1, 2027

Completion

Feb 1, 2027

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Silent AI Analysis of OR Count Radiographs
  Eligible OR count radiographs obtained during routine clinical care are automatically processed by an artificial intelligence system designed to detect and localize retained foreign objects. The system generates research outputs including detection probabilities, localization bounding boxes, and processing timestamps. During the prospective silent evaluation, these outputs are not displayed to clinicians and are not used for clinical decision-making or patient management.

Primary Outcome Measure

Sensitivity of the AI System for Retained Foreign Object Detection [ Time Frame: Through completion of the 12-month prospective study period ]

Central Contacts

• Harrison Bai, MD
  720-516-0637
  [email protected]

Locations (1)

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