Ultrasound Imaging of Anatomical StructuresNCT06025279
Musculoskeletal System Ultrasound Examination Data Collection Study for the Development of an Artificial Intelligence Software
An observational study of Ultrasound Imaging of Anatomical Structures and Musculoskeletal Diseases, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging of Anatomical Structures, Musculoskeletal Diseases
- What is being tested?
- Ultrasound Scan
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2023to 29 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 300 participants, divided between genders (150 females and 150 males), will take part in the study. These participants will include both healthy individuals and pathological conditions related to specific views of the musculoskeletal system. Their involvement will be based on informed consent. Pertinent data, such as medical history, body mass index (BMI), age, and gender, will be reported. The logistical expenses of the volunteers during the study will be covered by the sponsor, Smart Alfa Teknoloji San. ve Tic. A.Ş. The collection of raw ultrasound data will be undertaken by two experienced clinicians in physical medicine and rehabilitation, and ultrasound scanning. Their expertise ensures accurate data collection.
Who may be able to join
- Volunteers over the age of 18
- Able to accept and sign the Informed Consent Form before participating in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine
Altındağ, Ankara, 06230
About this study
Official title: Data Collection Study to Develop an Artificial Intelligence-Based Ultrasound Guidance Software (Curious) for Musculoskeletal Examinations
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?
Read the 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.
- Being tested
- Ultrasound Scan
- Keywords
- Artificial Intelligence, Ultrasound Imaging, Musculoskeletal System, Data Collection
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanOther
Clinical professionals will conduct non-invasive ultrasound scans from the specified body views and subsequently save the acquired data.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Assessment of image quality
The usability of the collected data in the artificial intelligence software will be verified.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start3 Aug 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Imaging of Anatomical StructuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ankara University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025279
- Sponsor's protocol ID
- SMARTALPHA-CURIOUS-1000
- Status last verified
- Apr 2024
- First submitted
- 29 Aug 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37572764Ozcakar 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.
PubMed 35802706
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Study to Develop an Artificial Intelligence-Based Ultrasound Guidance Software (Curious) for Musculoskeletal Examinations
- ClinicalTrials.gov ID
- NCT06025279
- Acronym / sponsor ID
- SMARTALPHA-CURIOUS-1000
- Keywords
- Artificial Intelligence, Ultrasound Imaging, Musculoskeletal System, Data Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Collaborators
- Ankara University
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 participants, divided between genders (150 females and 150 males), will take part in the study. These participants will include both healthy individuals and pathological conditions related to specific views of the musculoskeletal system. Their involvement will be based on informed consent. Pertinent data, such as medical history, body mass index (BMI), age, and gender, will be reported. The logistical expenses of the volunteers during the study will be covered by the sponsor, Smart Alfa Teknoloji San. ve Tic. A.Ş. The collection of raw ultrasound data will be undertaken by two experienced clinicians in physical medicine and rehabilitation, and ultrasound scanning. Their expertise ensures accurate data collection.
Key inclusion criteria (2 listed)
- Volunteers over the age of 18
- Able to accept and sign the Informed Consent Form before participating in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ScanClinical professionals will conduct non-invasive ultrasound scans from the specified body views and subsequently save the acquired data. | Other | – |
Primary outcome
Collecting ultrasound data for artificial intelligence software that highlighted structures
Time frame: 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.
1 secondary outcome
Assessment of image quality
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 37572764Gungor 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.
- Background: PubMed 35802706Ozcakar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Imaging of Anatomical Structures and Musculoskeletal Diseases, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting ultrasound data for artificial intelligence software that highlighted structures (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.