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ScanNav Anatomy PNB FDA Data Collection Plan

ScanNav Anatomy PNB FDA Data Collection Plan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05963230
Enrollment
47
Registered
2023-07-27
Start date
2023-07-01
Completion date
2023-07-21
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Recordings

Brief 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 will be collected in the form of scenes (target block view) and non-scenes (areas adjacent to the target block view).

Interventions

Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.

Sponsors

IntelligentUltrasound Limited
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male or female, at least 18 years of age; * Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound scan recordings6 monthsUltrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026