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OpenTrials
Completed

NCT Number: NCT07336407

Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination

This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images.

The software to be assessed is designed to assist physicians and healthcare professionals in performing ultrasound exams by classifying scan views and identifying key anatomical structures during a musculoskeletal ultrasound examination.

The main question the study aims to answer is whether the AI software performs safely and effectively for future clinical use.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Clinic Torrey Pines, La Jolla, California, United States

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About this study

This study is designed to validate the performance of the MSK Go software in classifying musculoskeletal ultrasound examination views and segmenting relevant anatomical structures in a U.S. population.

Data collection method and analysis:

A total of 79 subjects were enrolled and undergone shoulder, elbow, wrist/hand, knee, and foot/ankle scans at three clinical sites. Ultrasound examinations were performed by MSK ultrasound experts without using MSK Go.

Each participant spent approximately 30 minutes in the ultrasound scanning session. Demographic data were collected for all subjects. An FDA-cleared, commercially available ultrasound device was used at each location.

The collected ultrasound scans are then annotated by healthcare professionals with expertise in musculoskeletal sonography.

In a post hoc analysis, the ultrasound clips were processed using the AI software, and the software-generated classifications of views and segmentations of anatomical structures were compared with the reference annotations .

Convenience sampling was applied during data collection to ensure that participants represented a balanced distribution across age, gender, BMI, and ethnicity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of a signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

  • Pregnancy
  • Inability to lie flat
  • Open skin lesions or active infection at the scan site
  • Anatomical deformity in the joints to be scanned

Treatment and study plan

Ultrasound Scans

Device

Scanning for musculoskeletal examination views on shoulder, elbow, wrist/hand, knee, and foot/ankle.

Primary outcomes

  1. Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image

    Time frame: Up to 30 days from enrollment

    The performance based on the rate of the spatial (area) overlapping of supported structures

  2. Rae of correctly classifying the views of the joint

    Time frame: Up to 30 days from enrollment

    The performance based on the rate of correctly detecting views of the selected joint

Secondary outcomes

  1. Rate of correctly assigning anatomical structure completeness level for any scan view of the joint

    Time frame: Up to 30 days from enrollment

    The performance based on the completeness rate of detection level of the set of supported anatomical structures by the software

Sponsors and collaborators

Lead sponsor

Smart Alfa Teknoloji San. ve Tic. A.S.

Industry

Registry information

Official study title

Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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