NCT04830891

A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB

A Volunteer Study to Collect Imaging Data for the Development and Validation of Intelligent Ultrasound ScanNav Anatomy PNB

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: IntelligentUltrasound Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in Intelligent Ultrasound's offices at Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY, UK.

Detailed description

This is a single-centre, non-randomised, prospective study involving up to 100 participants. The data collected in this study will augment the data collected in ML2018\_AG\_01, ML2018\_AG\_02, IU2019\_AG\_03, and IU2020\_AG\_04. Phase I Collect data from participants for each indicated block area. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images. Phase II Validation will proceed by feeding the videos into the ScanNav AnatomyGuide system and recording the output anatomy highlighting, overlaid on the original ultrasound image. The overlaid video will be examined by experts to identify safety and performance issues.

Conditions

• Ultrasound Imaging of Anatomical Structures

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2021-04-05
• Last updated: 2022-05-05

Locations

1 site across 1 country: United Kingdom