Musculoskeletal System Ultrasound Examination Data Collection Study for the Development of an Artificial Intelligence Software

Completed

• Conditions: Ultrasound Imaging of Anatomical Structures; Musculoskeletal Diseases

• Registration Number: NCT06025279
• Lead Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.

Brief Summary

The primary objective of this observational study is to acquire ultrasound images (raw data) encompassing various planes within the musculoskeletal system. This data will be instrumental in the development of artificial intelligence-guided software. The study aims to enlist 300 volunteers, comprising individuals with both healthy musculoskeletal systems and those presenting pathologies. These participants will undergo ultrasound scans administered by two experienced professionals, employing FDA-cleared ultrasound devices.

The main question it aims to answer is:

-Are the collected ultrasound images of diagnostic quality?

Detailed Description

Ultrasound's cost-effective and user-friendly attributes have positioned it as a cornerstone in diagnosing musculoskeletal system disorders.

In this single-centered and prospective study, the study aims to enlist 300 volunteers, comprising both individuals with healthy musculoskeletal systems and those with pathologies. The collected ultrasound raw data will be used to train models for the identification and highlighting of key anatomical landmarks on ultrasound images. Participants' gender, age, BMI, and medical history will be considered and reported. All scans will be performed on FDA-cleared general-purpose ultrasound devices. Obtained images will be used to develop artificial intelligence-based medical software by Smart Alfa Teknoloji San. Ve Tic. A.Ş., Ankara, Turkey. Smart Alfa has similarly conducted a study in the field of anesthesia using the same method in Nerveblox artificial intelligence software.

The study methodology encompasses the following components:

* Specific body views, guided by established protocols, will be scanned from different body planes. The focus areas encompass musculoskeletal structures.

* A cohort of 300 volunteers, evenly distributed by gender (150 male, 150 female), will have their demographic data (BMI, gender, age) documented.

* To counteract potential biases, the sequence of volunteer participation will be randomized.

* Each scan is expected to take 45 minutes.

Study Timeline

• Study Start: 2023-08-03
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Volunteers over the age of 18
• Able to accept and sign the Informed Consent Form before participating in the study

Exclusion Criteria

• Volunteers below the age of 18
• Unwilling to accept or having psychiatric or neurological diseases to sign an Informed Consent Form before participating in the study
• Inability to lie flat
• Anatomical deformity in the area to be scanned

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collecting ultrasound data for artificial intelligence software that highlighted structures	4 months	The gathered images will serve the purpose of annotating anatomical landmarks, enabling the acquisition of diagnostically reliable images through artificial intelligence software. These annotated ultrasound images, validated by experts, will form the basis of a training dataset for the development of a machine learning algorithm.

Secondary Outcome Measures

Name	Time	Method
Assessment of image quality	4 months	The usability of the collected data in the artificial intelligence software will be verified.

Trial Locations

Locations (1)

Ankara University School of Medicine; 🇹🇷 Altındağ, Ankara, Turkey