ScanNav Anatomy PNB FDA Data Collection Plan

Completed

• Conditions: Ultrasound Recordings

• 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

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Study First Posted: 2023-07-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

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

Primary Outcome Measures

Name	Time	Method
Ultrasound scan recordings	6 months	Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.

Trial Locations

Locations (1)

Taylor Research; 🇺🇸 San Diego, California, United States