Ultrasound ScanNCT06920277
Ultrasound Image Collection for the Development of an AI Software
An observational study of Ultrasound Scan, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 1 site in United States.
Trial summary
This study is designed to collect ultrasound images from healthy volunteers in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Scan
- What is being tested?
- Ultrasound scans
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 31 Oct 2024
- 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: volunteers from the U.S. population
Who may be able to join
- Provision of signed and dated informed consent form
- At least 18 years of age and older
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health
Who cannot join
- Pregnancy
- Inability to lie to flat
- Any complaint or anatomical deformity on the regions to be scanned
Trial locations and contacts
1 site in 1 country.
United States1 site
Conference Room at Doubletree by Hilton Austin
Austin, Texas, 78752
About this study
Official title: Data Collection for the Development of Artificial Intelligence (AI) Software to Support Ultrasound-Guided Regional Anesthesia Procedures
This study is designed to collect ultrasound images from healthy volunteers in the U.S.
Read the detailed description
The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:
- Interscalene Brachial Plexus
- Supraclavicular Brachial Plexus
- Infraclavicular Brachial Plexus
- Cervical Plexus
- Axillary Brachial Plexus
- PECS I \& II
- Transversus Abdominis Plane (TAP)
- Rectus Sheath
- Femoral Nerve
- Adductor Canal
- Popliteal Sciatic
- Erector Spinae Plane (ESP)
- Conditions
- Ultrasound Scan
- Being tested
- Ultrasound scans
- Keywords
- Data collection, Artificial Intelligence, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scansDevice
10 seconds scanning for one block region
| Study group | Role | What they receive |
|---|---|---|
| U.S. population | Not described Receives: Device: Ultrasound scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected
Ultrasound scans will be collected and reviewed for quality and completeness. The outcome will be the number of ultrasound recordings that meet predefined criteria for image quality; correct anatomical region and clear visualization to support AI development.
Measured: Day 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start29 Oct 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ScanStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senanur Samur Duysal, Principal investigator, Smart Alfa Teknoloji San. ve Tic. A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920277
- Sponsor's protocol ID
- NRV-001-04
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for the Development of Artificial Intelligence (AI) Software to Support Ultrasound-Guided Regional Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT06920277
- Acronym / sponsor ID
- NRV-001-04
- Conditions
- Ultrasound Scan
- Keywords
- Data collection, Artificial Intelligence, Regional Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 9 Apr 2025 (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.
This study is designed to collect ultrasound images from healthy volunteers in the U.S.
Detailed description
The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:
- Interscalene Brachial Plexus
- Supraclavicular Brachial Plexus
- Infraclavicular Brachial Plexus
- Cervical Plexus
- Axillary Brachial Plexus
- PECS I \& II
- Transversus Abdominis Plane (TAP)
- Rectus Sheath
- Femoral Nerve
- Adductor Canal
- Popliteal Sciatic
- Erector Spinae Plane (ESP)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. population | – | Device: Ultrasound scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- volunteers from the U.S. population
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- At least 18 years of age and older
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health
Key exclusion criteria (3 listed)
- Pregnancy
- Inability to lie to flat
- Any complaint or anatomical deformity on the regions 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 scans10 seconds scanning for one block region | Device | U.S. population |
Primary outcome
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected
Time frame: Day 1, 2 and 3
Ultrasound scans will be collected and reviewed for quality and completeness. The outcome will be the number of ultrasound recordings that meet predefined criteria for image quality; correct anatomical region and clear visualization to support AI development.
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 9 Apr 2025.
- 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.
Senanur Samur Duysal principal investigator
Smart Alfa Teknoloji San. ve Tic. A.S.
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 Scan, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 1 site in United States.
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 4 inclusion and 3 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 9 Apr 2025. 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 United States. 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?
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected (time frame: Day 1, 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.