MedPath

ScanNav Anatomy PNB FDA Data Collection Plan

Completed
Conditions
Ultrasound Recordings
Interventions
Other: Ultrasound scans
Registration Number
NCT05963230
Lead Sponsor
IntelligentUltrasound Limited
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
47
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Volunteer ParticipantsUltrasound scansHealthy adult (18+ years old) volunteers
Primary Outcome Measures
NameTimeMethod
Ultrasound scan recordings6 months

Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Taylor Research

🇺🇸

San Diego, California, United States

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