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

Completed

• Conditions: Ultrasound Imaging of Anatomical Structures

• Registration Number: NCT04830891
• Lead Sponsor: IntelligentUltrasound Limited

Brief 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.

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in per-class Mean Intersection over Union (IoU) scores of deep-learning segmentation models compared to baseline models	6 months	The mean Intersection over Union will be computed for each class for each model trained with the enlarged dataset, using the existing unseen test data set. These scores will be compared with the scores from the existing baseline models to determine the effect of the enlarged training data

Trial Locations

Locations (1)

Intelligent Ultrasound Limited; 🇬🇧 Cardiff, Wales, United Kingdom