Ultrasound Imaging of Anatomical StructuresNCT03654300
A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.
An observational study of Ultrasound Imaging of Anatomical Structures, run by Medaphor Limited at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia. 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
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2018to 30 Oct 2018
- 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: Healthy volunteers, male and female, aged 18 years or more.
Who may be able to join
- Male or female, at least 18 years of age;
- Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:
- Adductor canal
- Popliteal fossa
- Fascia Iliaca
- Rectus sheath
- Axillary region
- Able to comprehend and sign the Informed Consent prior to enrolment in the study.
Who cannot join
- Aged <18 years of age;
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.
Read the detailed description
The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:
- Adductor canal
- Popliteal fossa
- Fascia Iliaca
- Rectus sheath
- Axillary region Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.
The videos will be segmented by hand to identify the relevant anatomical regions for each category.
The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Model development
models with a Mean intersection over Union score of 0.95 or better for each region in each category.
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 posted31 Aug 2018
- Study start14 Sep 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medaphor Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654300
- Sponsor's protocol ID
- ML2018_AG_01
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.
- ClinicalTrials.gov ID
- NCT03654300
- Acronym / sponsor ID
- ML2018_AG_01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Medaphor LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 31 Aug 2018 (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 aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.
Detailed description
The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:
- Adductor canal
- Popliteal fossa
- Fascia Iliaca
- Rectus sheath
- Axillary region Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.
The videos will be segmented by hand to identify the relevant anatomical regions for each category.
The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, male and female, aged 18 years or more.
Key inclusion criteria (8 listed)
- Male or female, at least 18 years of age;
- Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:
- Able to comprehend and sign the Informed Consent prior to enrolment in the study.
Key exclusion criteria (2 listed)
- Aged <18 years of age;
- Unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Model development
Time frame: 6 months
models with a Mean intersection over Union score of 0.95 or better for each region in each category.
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 25 Jul 2019.
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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, run by Medaphor Limited at 1 site in United Kingdom.
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 8 inclusion and 2 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 25 Jul 2019. 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 Kingdom. 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?
Model development (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 25 Jul 2019.