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

Musculoskeletal Diseases Clinical Trial

Official title:

Data Collection Study to Develop an Artificial Intelligence-Based Ultrasound Guidance Software (Curious) for Musculoskeletal Examinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025279
• Other study ID #: SMARTALPHA-CURIOUS-1000
• Status: Completed
• Start date: August 3, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: April 2024
• Source: Smart Alfa Teknoloji San. ve Tic. A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Ultrasound Imaging of Anatomical Structures

Intervention

Other:
• Ultrasound Scan
Clinical professionals will conduct non-invasive ultrasound scans from the specified body views and subsequently save the acquired data.

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Altindag	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Smart Alfa Teknoloji San. ve Tic. A.S.	Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Gungor I, Gunaydin B, Buyukgebiz Yesil BM, Bagcaz S, Ozdemir MG, Inan G, Oktar SO. Evaluation of the effectiveness of artificial intelligence for ultrasound guided peripheral nerve and plane blocks in recognizing anatomical structures. Ann Anat. 2023 Oct;250:152143. doi: 10.1016/j.aanat.2023.152143. Epub 2023 Aug 11. — View Citation

Ozcakar L, Tok F, Ricci V, Mezian K, Wu CH, Wu WT, Park GY, Kwon DR, Prieto MG, Dughbaj M, Dogan Y, Aksoz B, Guvener O, Ekiz T, Tiras M, Karacoban L, Menderes Y, Ciftci E, Ilicepinar OF, Kaya U, Kara M, Chang KV. Artificial Intelligence Featuring EURO-MUSCULUS/USPRM Basic Scanning Protocols. Am J Phys Med Rehabil. 2022 Nov 1;101(11):e174-e175. doi: 10.1097/PHM.0000000000002070. Epub 2022 Jul 7. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collecting ultrasound data for artificial intelligence software that highlighted structures	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.	4 months
Secondary	Assessment of image quality	The usability of the collected data in the artificial intelligence software will be verified.	4 months