Ultrasound RecordingsNCT05963230
ScanNav Anatomy PNB FDA Data Collection Plan
An observational study of Ultrasound Recordings, run by IntelligentUltrasound Limited at 1 site in United States.
Trial summary
To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories: Femoral Nerve (Femoral) Interpectoral (PECS I) and pectoserratus (PECS II) Transversus abdominis plane (TAP) Serratus Plane (SP) Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Recordings
- What is being tested?
- Ultrasound scans
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 21 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers from the San Diego, California, USA 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.
- Previous history of medical interventions that may affect the anatomy of the chosen scan areas, e.g. hip replacements.
Trial locations and contacts
1 site in 1 country.
About this study
To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories:
- Femoral Nerve (Femoral)
- Interpectoral (PECS I) and pectoserratus (PECS II)
- Transversus abdominis plane (TAP)
- Serratus Plane (SP)
- Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).
- Conditions
- Ultrasound Recordings
- 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 |
|---|---|---|
| Volunteer Participants | 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 experts in ultrasound-guided regional anaesthesia.
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 Jul 2023
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound RecordingsStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelligentUltrasound Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Bowness, Dr, Principal investigator, Intelligent Ultrasound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963230
- Sponsor's protocol ID
- IU2023_AG_12
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2023
- Last updated
- 28 Mar 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ScanNav Anatomy PNB FDA Data Collection Plan
- ClinicalTrials.gov ID
- NCT05963230
- Acronym / sponsor ID
- IU2023_AG_12
- Conditions
- Ultrasound Recordings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- IntelligentUltrasound LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (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.
To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories:
- Femoral Nerve (Femoral)
- Interpectoral (PECS I) and pectoserratus (PECS II)
- Transversus abdominis plane (TAP)
- Serratus Plane (SP)
- Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer Participants | – | 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
- Volunteers from the San Diego, California, USA 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 (3 listed)
- Aged <18 years of age;
- Unwilling or unable to provide informed consent.
- Previous history of medical interventions that may affect the anatomy of the chosen scan areas, e.g. hip replacements.
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 | Volunteer Participants |
Primary outcome
Ultrasound scan recordings
Time frame: 6 months
Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.
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
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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.
James Bowness, 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 Recordings, run by IntelligentUltrasound Limited 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 2 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 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 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?
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.