Ultrasound Imaging of Anatomical StructuresNCT06375603
Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software
An observational study of Ultrasound Imaging of Anatomical Structures and Nerve Block, 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) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging of Anatomical Structures, Nerve Block
- What is being tested?
- Ultrasound scans
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 May 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 healthy volunteers will participate in the data collection study. Their weight, height, age, and gender information will be documented.
Who may be able to join
- Male at least 18 years of age
- Female at least 18 years of age
- Health volunteers
- Able to confirm and sign the Informed Consent Form before enrolment the study
Who cannot join
- Male below 18 years of age
- Female below 18 years of age
- Unwilling to participate or unable to sign an informed consent form
- Inability to lie flat
- Anatomical deformity in the area to be scanned for nerve and plane blocks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine
Ankara, 06230
About this study
The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices.
Read the detailed description
Ultrasound-guided nerve and plane blocks have facilitated regional anesthesia by providing clinicians with real-time imaging capabilities for precise needle placement and application of local anesthetics. These techniques involve the use of ultrasound technology to visualize nerves and surrounding anatomical structures, allowing for accurate identification and targeting of specific nerve pathways. Additionally, the integration of artificial intelligence (AI) into ultrasound-guided nerve blocks offers further enhancements to this practice. AI algorithms can assist clinicians in image interpretation, needle localization, and decision-making, streamlining procedural workflows and reducing the risk of complications. The sponsor, Smart Alfa Teknoloji San. Ve Tic. A.Ş., located in Ankara, Turkey, aims to collect data from planned regions of volunteers to develop artificial intelligence-supported nerve block software (Nerveblox). The gathered data will be utilized for training, validation, and test processes of the AI algorithm.
The study methodology encompasses the following components:
- A cohort of 200 volunteers, evenly distributed by gender (100 male, 100 female), will have their demographic data (BMI, gender, age) documented.
- Each scan from one volunteer is expected to take 30 minutes.
- Being tested
- Ultrasound scans
- Keywords
- Ultrasound Imaging, Artificial Intelligence, Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scansOther
Clinical experts will conduct non-invasive ultrasound scans from the specified nerve or plane block views and record the acquired data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of image quality
Collected images will be used for labeling anatomical landmarks for development of Nerveblox.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Dec 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- Investigators
- Süheyla Karadağ Erkoç, Assoc. Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375603
- Sponsor's protocol ID
- SMARTALPHA-NERVEBLOX-1001
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software
- ClinicalTrials.gov ID
- NCT06375603
- Acronym / sponsor ID
- SMARTALPHA-NERVEBLOX-1001
- Keywords
- Ultrasound Imaging, Artificial Intelligence, Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Collaborators
- Ankara University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 Apr 2024 (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) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices.
Detailed description
Ultrasound-guided nerve and plane blocks have facilitated regional anesthesia by providing clinicians with real-time imaging capabilities for precise needle placement and application of local anesthetics. These techniques involve the use of ultrasound technology to visualize nerves and surrounding anatomical structures, allowing for accurate identification and targeting of specific nerve pathways. Additionally, the integration of artificial intelligence (AI) into ultrasound-guided nerve blocks offers further enhancements to this practice. AI algorithms can assist clinicians in image interpretation, needle localization, and decision-making, streamlining procedural workflows and reducing the risk of complications. The sponsor, Smart Alfa Teknoloji San. Ve Tic. A.Ş., located in Ankara, Turkey, aims to collect data from planned regions of volunteers to develop artificial intelligence-supported nerve block software (Nerveblox). The gathered data will be utilized for training, validation, and test processes of the AI algorithm.
The study methodology encompasses the following components:
- A cohort of 200 volunteers, evenly distributed by gender (100 male, 100 female), will have their demographic data (BMI, gender, age) documented.
- Each scan from one volunteer is expected to take 30 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 healthy volunteers will participate in the data collection study. Their weight, height, age, and gender information will be documented.
Key inclusion criteria (4 listed)
- Male at least 18 years of age
- Female at least 18 years of age
- Health volunteers
- Able to confirm and sign the Informed Consent Form before enrolment the study
Key exclusion criteria (5 listed)
- Male below 18 years of age
- Female below 18 years of age
- Unwilling to participate or unable to sign an informed consent form
- Inability to lie flat
- Anatomical deformity in the area to be scanned for nerve and plane blocks
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 scansClinical experts will conduct non-invasive ultrasound scans from the specified nerve or plane block views and record the acquired data. | Other | – |
Primary outcome
Assessment of image quality
Time frame: 6 months
Collected images will be used for labeling anatomical landmarks for development of Nerveblox.
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 19 Apr 2024.
- 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.
Süheyla Karadağ Erkoç, Assoc. Prof. principal investigator
Ankara University
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 Nerve Block, 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 4 inclusion and 5 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 19 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?
Assessment of image quality (time frame: 6 months). 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 19 Apr 2024.