Artificial IntelligentNCT06283485
Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks
An observational study of Artificial Intelligent and Ultrasound Therapy; Complications, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Artificial Intelligent, Ultrasound Therapy; Complications, Nerve Block
- What is being tested?
- ultrasound examination
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 25 Apr 2025
- How long will I take part?
- 2 Months
- 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
- Adult, Older adult
Study population: For the first phase of the study, 150 volunteers, 75 women and 75 men, were determined by the Smart Alfa company, which will produce artificial intelligence. In the sample size analysis conducted for the second stage, it was determined that there should be 19 participants for each group with an alpha margin of error of 0.05, with a power rate of 80% for comparison of two groups. The effect used for this calculation was calculated as 0.837, and the actual power was calculated as 0.812, based on similar studies. As a result of the analysis, considering the drop out rate, it was planned to recruit 20 participants for each group. (20 women - 20 men)
Who may be able to join
- Agreeing to take ultrasound images
- Healthy - No comorbidities
- Adult individuals between the ages of 18-65
Who cannot join
- Those who do not accept ultrasound images
- Individuals under 18 years of age
- with comorbidities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Study of an AI-based, Real-time Anatomy Identification Tool for Use in Ultrasound-guided PENG (Pericapsular Nerve Block) and Suprainguinal Fascia Iliaca Blocks
Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.
Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?
Read more
Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.
Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety.
Read the detailed description
Research processes; The study will consist of two stages. Phase 1: PENG, collection of sonoanatomical images of Supraingiuinal Fascia Iliaca block and development of artificial intelligence software (in healthy volunteers without invasive procedures) Stage 2: Conducting validation study with the developed artificial intelligence
Stage 1: Taking ultrasound images from healthy volunteers (150 volunteers) to produce artificial intelligence - How to take PENG and Suprainguinal Fascia Iliaca Block sonoanatomical images is as follows.
1.1) PENG (Pericapsular Nerve Group Block): Images will be taken with both linear and convex probes. Sonoanatomical information will be collected from healthy volunteers and no invasive procedures will be performed. 150 (75 women -75 men) healthy volunteers who agree to have ultrasound images taken will be included.
1.2) Suprainguinal Fascia Iliaca Block: Images will be taken with a linear probe. Sonoanatomical information will be collected from healthy volunteers and no invasive procedures will be performed. 150 (75 female-75 male) healthy volunteers who agree to have ultrasound images taken will be included.
In the first phase of this study, thanks to the PENG and Suprainguinal Fascia Iliaca block images collected from volunteers, the artificial intelligence technology Smart Alfa Teknoloji San. recognizes and marks the anatomical structures of this region. and Tic. Inc. It will be developed by and added to Nerveblox software. After PENG and Suprainguinal Fascia Iliaca blocks are included in the software, Nerveblox software will be used during validation in the second phase of the study.
Phase 2: In the second phase of the study, Smart Alfa Teknoloji San. and Tic. Inc. Artificial intelligence technology called Nerveblox, which was developed with the data received in the first stage with the support of the company, will be used. It is the validation and accuracy study of the artificial intelligence technology developed in the first stage. The accuracy study will be conducted on 40 healthy volunteers. 20 men and 20 women will be included in the study.
Thanks to the Nerveblox artificial intelligence technology developed at this stage, the accuracy of the anatomical structures marked and colored by the regional-specific artificial intelligence; It will be evaluated by 6 experienced anesthesiologists based on ultrasound image scans made by 2nd, 3rd and 4th year assistants (two assistants from each year). The second phase is the validation phase and the validators will be experienced anesthesiologists (at least five years of specialized experience). Validators will score the accuracy of representation of each predefined anatomical landmark using a 5-point scale (1: Very Poor, 2: Poor, 3: Good, 4: Very Good, 5: Excellent); Accuracy is defined as expert opinion on how software-generated landmark labels represent true anatomy in raw ultrasonography images.
- Being tested
- ultrasound examination
- Keywords
- Artificial intelligent, peripheric nerve block, pericapsular nerve block, Suprainguinal Fascia Iliaca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationDevice
Phase 1 1: Taking ultrasound images from healthy volunteers (150 volunteers) to produce artificial intelligence - How to take PENG and Suprainguinal Fascia Iliaca Block sonoanatomical images is as follows.
Phase 2: In the second phase of the study, Smart Alfa Teknoloji San. and Tic. Inc. Artificial intelligence technology called Nerveblox, which was developed with the data received in the first stage with the support of the company, will be used. It is the validation and accuracy study of the artificial intelligence technology developed in the first stage. The accuracy study will be conducted on 40 healthy volunteers. 20 men and 20 women will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Male | Phase 1: Creating artificial intelligence from ultrasound scans of 150 healthy volunteers Sonoanatomical PENG and Suprainguinal Fascia Iliaca Block pictures are taken as follows.
1) PENG (Pericapsular Nerve Group Block): Linear and convex probes will be used to collect images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy volunteers (75 women-75 males) will be ultrasounded.
1.2) Suprainguinal Fascia Iliaca Block: Linear probe images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy individuals (75 female-75 male) will be ultrasounded.
Phase 2: Smart Alfa Teknoloji San. and Tic. Inc. will use Nerveblox, an artificial intelligence system built using data from the first stage, in the second part of the study. First-stage artificial intelligence technology validation and accuracy study. The accuracy study will involve 40 healthy volunteers. 20 men and 20 women will be studied. Receives: Device: ultrasound examination | |
| Female | Phase 1: Creating artificial intelligence from ultrasound scans of 150 healthy volunteers Sonoanatomical PENG and Suprainguinal Fascia Iliaca Block pictures are taken as follows.
1) PENG (Pericapsular Nerve Group Block): Linear and convex probes will be used to collect images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy volunteers (75 women-75 males) will be ultrasounded.
1.2) Suprainguinal Fascia Iliaca Block: Linear probe images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy individuals (75 female-75 male) will be ultrasounded. Receives: Device: ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artificial intelligence Program size
Thanks to the PENG and Suprainguinal Fascia Iliaca block images collected from volunteers in the first phase of this study, the artificial intelligence technology Smart Alfa company recognizes and marks the anatomical structures of these four regions. It will be developed by and added to Nerveblox software.
Measured: Based, during the ultrasonography.
Score of assessment the pictures
In the second phase, thanks to the Nerveblox artificial intelligence technology developed, the accuracy of the anatomical structures marked and colored by the regional-specific artificial intelligence; It will be evaluated based on ultrasound image scans made by 2nd, 3rd and 4th year assistants and by anesthesiologists with at least 5 years of experience.
Measured: After the ultrasonography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Dec 2023
- Primary completion15 Apr 2025 (estimated)
- Study completion25 Apr 2025 (estimated)
Why it stopped: We encountered lots of technical problems and we could not handle and solve these problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligentStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Betül Afşar
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
- Investigators
- Yasin Tire, Principal investigator, Konya City HospitalBetül Afşar, Study director, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283485
- Sponsor's protocol ID
- Study Artificial intelligence
- Status last verified
- Aug 2025
- First submitted
- 15 Feb 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We deeen to talk to people who is volunteer for the study and company for that.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Study of an AI-based, Real-time Anatomy Identification Tool for Use in Ultrasound-guided PENG (Pericapsular Nerve Block) and Suprainguinal Fascia Iliaca Blocks
- ClinicalTrials.gov ID
- NCT06283485
- Acronym / sponsor ID
- Study Artificial intelligence
- Keywords
- Artificial intelligent, peripheric nerve block, pericapsular nerve block, Suprainguinal Fascia Iliaca
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We encountered lots of technical problems and we could not handle and solve these problems.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Collaborators
- Betül Afşar
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 25 Apr 2025 (estimated)
- First posted
- 28 Feb 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.
Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.
Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?
Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.
Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety.
Detailed description
Research processes; The study will consist of two stages. Phase 1: PENG, collection of sonoanatomical images of Supraingiuinal Fascia Iliaca block and development of artificial intelligence software (in healthy volunteers without invasive procedures) Stage 2: Conducting validation study with the developed artificial intelligence
Stage 1: Taking ultrasound images from healthy volunteers (150 volunteers) to produce artificial intelligence - How to take PENG and Suprainguinal Fascia Iliaca Block sonoanatomical images is as follows.
1.1) PENG (Pericapsular Nerve Group Block): Images will be taken with both linear and convex probes. Sonoanatomical information will be collected from healthy volunteers and no invasive procedures will be performed. 150 (75 women -75 men) healthy volunteers who agree to have ultrasound images taken will be included.
1.2) Suprainguinal Fascia Iliaca Block: Images will be taken with a linear probe. Sonoanatomical information will be collected from healthy volunteers and no invasive procedures will be performed. 150 (75 female-75 male) healthy volunteers who agree to have ultrasound images taken will be included.
In the first phase of this study, thanks to the PENG and Suprainguinal Fascia Iliaca block images collected from volunteers, the artificial intelligence technology Smart Alfa Teknoloji San. recognizes and marks the anatomical structures of this region. and Tic. Inc. It will be developed by and added to Nerveblox software. After PENG and Suprainguinal Fascia Iliaca blocks are included in the software, Nerveblox software will be used during validation in the second phase of the study.
Phase 2: In the second phase of the study, Smart Alfa Teknoloji San. and Tic. Inc. Artificial intelligence technology called Nerveblox, which was developed with the data received in the first stage with the support of the company, will be used. It is the validation and accuracy study of the artificial intelligence technology developed in the first stage. The accuracy study will be conducted on 40 healthy volunteers. 20 men and 20 women will be included in the study.
Thanks to the Nerveblox artificial intelligence technology developed at this stage, the accuracy of the anatomical structures marked and colored by the regional-specific artificial intelligence; It will be evaluated by 6 experienced anesthesiologists based on ultrasound image scans made by 2nd, 3rd and 4th year assistants (two assistants from each year). The second phase is the validation phase and the validators will be experienced anesthesiologists (at least five years of specialized experience). Validators will score the accuracy of representation of each predefined anatomical landmark using a 5-point scale (1: Very Poor, 2: Poor, 3: Good, 4: Very Good, 5: Excellent); Accuracy is defined as expert opinion on how software-generated landmark labels represent true anatomy in raw ultrasonography images.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Device: ultrasound examinationPhase 1: Creating artificial intelligence from ultrasound scans of 150 healthy volunteers Sonoanatomical PENG and Suprainguinal Fascia Iliaca Block pictures are taken as follows. 1) PENG (Pericapsular Nerve Group Block): Linear and convex probes will be used to collect images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy volunteers (75 women-75 males) will be ultrasounded. 1.2) Suprainguinal Fascia Iliaca Block: Linear probe images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy individuals (75 female-75 male) will be ultrasounded. Phase 2: Smart Alfa Teknoloji San. and Tic. Inc. will use Nerveblox, an artificial intelligence system built using data from the first stage, in the second part of the study. First-stage artificial intelligence technology validation and accuracy study. The accuracy study will involve 40 healthy volunteers. 20 men and 20 women will be studied. |
| Female | – | Device: ultrasound examinationPhase 1: Creating artificial intelligence from ultrasound scans of 150 healthy volunteers Sonoanatomical PENG and Suprainguinal Fascia Iliaca Block pictures are taken as follows. 1) PENG (Pericapsular Nerve Group Block): Linear and convex probes will be used to collect images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy volunteers (75 women-75 males) will be ultrasounded. 1.2) Suprainguinal Fascia Iliaca Block: Linear probe images. No invasive procedures will be conducted on healthy subjects for sonoanatomical data. 150 healthy individuals (75 female-75 male) will be ultrasounded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For the first phase of the study, 150 volunteers, 75 women and 75 men, were determined by the Smart Alfa company, which will produce artificial intelligence. In the sample size analysis conducted for the second stage, it was determined that there should be 19 participants for each group with an alpha margin of error of 0.05, with a power rate of 80% for comparison of two groups. The effect used for this calculation was calculated as 0.837, and the actual power was calculated as 0.812, based on similar studies. As a result of the analysis, considering the drop out rate, it was planned to recruit 20 participants for each group. (20 women - 20 men)
Key inclusion criteria (3 listed)
- Agreeing to take ultrasound images
- Healthy - No comorbidities
- Adult individuals between the ages of 18-65
Key exclusion criteria (4 listed)
- Those who do not accept ultrasound images
- Individuals under 18 years of age
- with comorbidities
- Pregnancy
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 examinationPhase 1 1: Taking ultrasound images from healthy volunteers (150 volunteers) to produce artificial intelligence - How to take PENG and Suprainguinal Fascia Iliaca Block sonoanatomical images is as follows. Phase 2: In the second phase of the study, Smart Alfa Teknoloji San. and Tic. Inc. Artificial intelligence technology called Nerveblox, which was developed with the data received in the first stage with the support of the company, will be used. It is the validation and accuracy study of the artificial intelligence technology developed in the first stage. The accuracy study will be conducted on 40 healthy volunteers. 20 men and 20 women will be included in the study. | Device | Female, Male |
Primary outcome
Artificial intelligence Program size
Time frame: Based, during the ultrasonography.
Thanks to the PENG and Suprainguinal Fascia Iliaca block images collected from volunteers in the first phase of this study, the artificial intelligence technology Smart Alfa company recognizes and marks the anatomical structures of these four regions. It will be developed by and added to Nerveblox software.
Score of assessment the pictures
Time frame: After the ultrasonography.
In the second phase, thanks to the Nerveblox artificial intelligence technology developed, the accuracy of the anatomical structures marked and colored by the regional-specific artificial intelligence; It will be evaluated based on ultrasound image scans made by 2nd, 3rd and 4th year assistants and by anesthesiologists with at least 5 years of experience.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided. We deeen to talk to people who is volunteer for the study and company for that.
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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.
Yasin Tire principal investigator
Konya City Hospital
Betül Afşar study director
Konya City Hospital
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 Artificial Intelligent and Ultrasound Therapy; Complications, run by Konya City Hospital 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 3 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: withdrawn, as of the sponsor's last update on 13 Aug 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Artificial intelligence Program size (time frame: Based, during the ultrasonography.). The study lists 2 primary outcomes in all. 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 13 Aug 2025.