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

Ultrasound Imaging of Anatomical Structures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830891
• Other study ID #: IU2021_AG_05
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2022
• Source: IntelligentUltrasound Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ultrasound Imaging of Anatomical Structures

Locations

Country	Name	City	State
United Kingdom	Intelligent Ultrasound Limited	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
IntelligentUltrasound Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in per-class Mean Intersection over Union (IoU) scores of deep-learning segmentation models compared to baseline models	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	6 months