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

NCT07336407 | Completed FDA Device

• 1 other identifier: MSK-001-02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ultrasound Imaging of Anatomical Structures

Keywords

Musculoskeletal; Artificial Intelligence; ultrasound

Outcome Measures

Primary Outcomes (2)

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

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

  Up to 30 days from enrollment

• Rae of correctly classifying the views of the joint

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

  Up to 30 days from enrollment

Secondary Outcomes (1)

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

  Up to 30 days from enrollment

Study Arms (1)

U.S population

OTHER

Device: Ultrasound Scans

Interventions

Ultrasound Scans DEVICE

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

U.S population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Smart Alfa Teknoloji San. ve Tic. A.S.: lead

Study Sites (3)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Location

AABP Integrative Pain Care and Wellness Clinic

Brooklyn, New York, 11204, United States

Location

Memorial Hermann Houston Health & Sports Medicine

Woodland, Texas, 77380, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 13, 2026
• Study Start: September 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)