UltrasoundNCT05963243
Automated Dating Scan Probe Pressure Data Collection Plan
An observational study of Ultrasound, run by IntelligentUltrasound Limited at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to collect data in the form of ultrasound recordings from healthy volunteers, to aid the development of an Artificial Intelligence model that can identify ultrasound probe pressure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound
- What is being tested?
- Ultrasound Scans
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 12 Jan 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: Healthy adult volunteers from the South Wales region.
Who may be able to join
- Male or female, at least 18 years of age;
- 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
Official title: A Volunteer Study to Collect Imaging Data for the Development of Identifying Probe Pressure as Part of ScanNav Assist Automated Dating Scan
The goal of this observational study is to collect data in the form of ultrasound recordings from healthy volunteers, to aid the development of an Artificial Intelligence model that can identify ultrasound probe pressure.
- Conditions
- Ultrasound
- Being tested
- Ultrasound Scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScansOther
Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy adult (18+ years old) volunteers Receives: Other: Ultrasound Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound scan recordings
Ultrasound scan recordings collected by the volunteer healthy participants of an abdominal self-scan.
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 posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion11 Dec 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelligentUltrasound Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Margetts, Dr, Principal investigator, Intelligent Ultrasound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963243
- Sponsor's protocol ID
- IU2023_WH_02
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2023
- Last updated
- 28 Mar 2024
- Results posted
- 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 28 Mar 2024. 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 Identifying Probe Pressure as Part of ScanNav Assist Automated Dating Scan
- ClinicalTrials.gov ID
- NCT05963243
- Acronym / sponsor ID
- IU2023_WH_02
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IntelligentUltrasound LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 27 Jul 2023 (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 goal of this observational study is to collect data in the form of ultrasound recordings from healthy volunteers, to aid the development of an Artificial Intelligence model that can identify ultrasound probe pressure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Ultrasound ScansHealthy adult (18+ years old) volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers from the South Wales region.
Key inclusion criteria (2 listed)
- Male or female, at least 18 years of age;
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ScansUltrasound scans collected by experts in ultrasound-guided regional anaesthesia. | Other | Healthy Volunteers |
Primary outcome
Ultrasound scan recordings
Time frame: 6 months
Ultrasound scan recordings collected by the volunteer healthy participants of an abdominal self-scan.
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 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
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.
Steve Margetts, Dr principal investigator
Intelligent Ultrasound
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, run by IntelligentUltrasound 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 2 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 28 Mar 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 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?
Ultrasound scan recordings (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 28 Mar 2024.