Ultrasound Imaging of Anatomical StructuresNCT06878911
Clinical Validation of Nerveblox, an Artificial Intelligence Software to Support Ultrasound-Guided Regional Anesthesia Procedures
A study testing Ultrasound Scans in people with Ultrasound Imaging of Anatomical Structures, run by Smart Alfa Teknoloji San. ve Tic. A.S. at 1 site in United States.
Trial summary
This single-center, prospective study is being conducted at AABP Integrative Pain Care and Wellness in Brooklyn, New York, USA. The aim of this study is to collect ultrasound images from healthy volunteers and evaluate the performance of the Nerveblox software using this image dataset. 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
- What is being tested?
- Ultrasound Scans
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 23 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Provision of signed and dated informed consent form
- 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
AABP Integrative Pain Care and Wellness Clinic
Brooklyn, New York, 11204
About this study
Official title: Data Collection for the Validation of an AI Software to Support Ultrasound-Guided Regional Anesthesia Procedures
This single-center, prospective study is being conducted at AABP Integrative Pain Care and Wellness in Brooklyn, New York, USA. The aim of this study is to collect ultrasound images from healthy volunteers and evaluate the performance of the Nerveblox software using this image dataset. Nerveblox is a software as a medical device which is designed to assist anesthesiologist for ultrasound-guided regional anesthesia, prior to needling procedure.
Read the detailed description
This study aims to validate the performance of AI technology in regional anesthesia through a clinical evaluation conducted on the U.S. population.
Data collection method and Analysis:
A total of 40 healthy subjects were enrolled and scanned by three different expert anesthesiologists. Twelve different peripheral nerve and plane block regions supported by the Nerveblox software were scanned bilaterally. Each participant spent approximately 30 minutes in the ultrasound scanning session, with each ultrasound clip lasting 10 seconds.
Age, gender, weight, and height data were collected and reported for each subject. Subjects were selected to balance the BMI distribution between those with BMI < 30 kg/m² and those with BMI ≥ 30 kg/m². An FDA-cleared, commercially available ultrasound device was used during the scanning process, and the Nerveblox software was not utilized in the data collection sessions.
Collected ultrasound clips included both ideal and non-ideal block views. The collected ultrasound scans were processed post hoc by the Nerveblox software, and the resulting outputs, alongside the raw ultrasound images, will be assessed by a panel of expert anesthesiologists. These clips were reviewed by two separate groups of reviewers, each consisting of three members.
Reviewers were asked to evaluate:
- Highlighting of Safety-Critical Anatomical Structures: For each safety-critical anatomical landmark on each clip, the majority opinion (at least 2 out of 3) was used to determine the overall panel results.
- Image Quality: Experts rated image quality on a scale from 1 to 5. These results were then converted to a binary measure for analysis.
- Effect of color highlighting on the perceived risks of ultrasound-guided regional anesthesia
Data were expressed as frequencies and shown as a percentage of the total clips analyzed. Inter-rater agreement was reported by block region.
- Being tested
- Ultrasound Scans
- Keywords
- 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 | Other | Not described Receives: Device: Ultrasound Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance assessment of anatomical landmark detection and highlighting of Nerveblox Software
The proportion of structures correctly identified by the software to all structures
Measured: Up to 35 days from enrollment
Secondary outcomes (1)
Image quality assessment
The agreement assesment between the Nerveblox Software's image quality grading and experts opinion for image quality
Measured: Up to 35 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start13 Jan 2025
- Primary completion23 Feb 2025
- Study completion23 Feb 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- Gary Scott Shwartz, M.D., Principal investigator, AABP Integrative Pain Care and Wellness Clinic, Brooklyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878911
- Sponsor's protocol ID
- NRV-001-05
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 17 Mar 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for the Validation of an AI Software to Support Ultrasound-Guided Regional Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT06878911
- Acronym / sponsor ID
- NRV-001-05
- Keywords
- Artificial Intelligence, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 23 Feb 2025 (actual)
- First posted
- 17 Mar 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 single-center, prospective study is being conducted at AABP Integrative Pain Care and Wellness in Brooklyn, New York, USA. The aim of this study is to collect ultrasound images from healthy volunteers and evaluate the performance of the Nerveblox software using this image dataset. Nerveblox is a software as a medical device which is designed to assist anesthesiologist for ultrasound-guided regional anesthesia, prior to needling procedure.
Detailed description
This study aims to validate the performance of AI technology in regional anesthesia through a clinical evaluation conducted on the U.S. population.
Data collection method and Analysis:
A total of 40 healthy subjects were enrolled and scanned by three different expert anesthesiologists. Twelve different peripheral nerve and plane block regions supported by the Nerveblox software were scanned bilaterally. Each participant spent approximately 30 minutes in the ultrasound scanning session, with each ultrasound clip lasting 10 seconds.
Age, gender, weight, and height data were collected and reported for each subject. Subjects were selected to balance the BMI distribution between those with BMI < 30 kg/m² and those with BMI ≥ 30 kg/m². An FDA-cleared, commercially available ultrasound device was used during the scanning process, and the Nerveblox software was not utilized in the data collection sessions.
Collected ultrasound clips included both ideal and non-ideal block views. The collected ultrasound scans were processed post hoc by the Nerveblox software, and the resulting outputs, alongside the raw ultrasound images, will be assessed by a panel of expert anesthesiologists. These clips were reviewed by two separate groups of reviewers, each consisting of three members.
Reviewers were asked to evaluate:
- Highlighting of Safety-Critical Anatomical Structures: For each safety-critical anatomical landmark on each clip, the majority opinion (at least 2 out of 3) was used to determine the overall panel results.
- Image Quality: Experts rated image quality on a scale from 1 to 5. These results were then converted to a binary measure for analysis.
- Effect of color highlighting on the perceived risks of ultrasound-guided regional anesthesia
Data were expressed as frequencies and shown as a percentage of the total clips analyzed. Inter-rater agreement was reported by block region.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. Population | Other | Device: Ultrasound Scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent form
- 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
Performance assessment of anatomical landmark detection and highlighting of Nerveblox Software
Time frame: Up to 35 days from enrollment
The proportion of structures correctly identified by the software to all structures
1 secondary outcome
Image quality assessment
Time frame: Up to 35 days from enrollment
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 17 Mar 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.
Gary Scott Shwartz, M.D. principal investigator
AABP Integrative Pain Care and Wellness Clinic, Brooklyn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Scans in people with Ultrasound Imaging of Anatomical Structures, 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 3 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 17 Mar 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?
Performance assessment of anatomical landmark detection and highlighting of Nerveblox Software (time frame: Up to 35 days from enrollment). 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 17 Mar 2025.