Recruiting

Artificial Intelligence

Sponsor:

University of Colorado, Denver

Code:

NCT07858162

Conditions

Retained Foreign Object

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Retained Foreign Object

Study ID

NCT07858162

Start date

Feb 1, 2026

Status verified date

Sep, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older.
  • Undergoing intraoperative radiography during routine clinical care for evaluation of a possible retained foreign object.
  • Radiographic examination identified using the institutional OR count imaging protocol, including "XR OR COUNT PROTOCOL W/WO POSITIVE CONTROL" or an equivalent institutional protocol label used for OR count imaging during the study period.

Exclusion Criteria:

  • Radiographic examination lacking usable imaging data.
  • Insufficient clinical or imaging information to establish an adequate reference standard for analysis.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Harrison Bai, MD

720-516-0637harrison.bai@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Harrison Bai

720-516-0637harrison.bai@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Retained Foreign Object
  • Retained Surgical Item
  • Retained Foreign Body
  • Artificial Intelligence
  • Deep Learning
  • Object Detection
  • Intraoperative Radiography
  • OR Count Radiograph
  • Surgical Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.