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

Intelligent Ultrasound

Status: Completed

Conditions: Ultrasound Imaging of Anatomical Structures

Study type: Observational

Funder types: Industry

Identifiers

NCT04830891

IU2021_AG_05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Potential participants who meet the following criteria will be considered eligible for the study:

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

Exclusion criteria

Potential participants who meet the following criteria will NOT be eligible for the study:

1. Aged <18 years of age;
2. Unwilling or unable to provide informed consent;
3. Previous surgery or trauma to the affected area.