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

NCT04830891 | Completed

• 1 other identifier: IU2021_AG_05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Imaging of Anatomical Structures

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be sourced initially from Intelligent Ultrasound's employees. If additional volunteers are required, adverts will be placed online. Intelligent Ultrasound will make cash payments of up to £40 to non-employee volunteers, to compensate them for their time

You may qualify if:

• Potential participants who meet the following criteria will be considered eligible for the study:
• Male or female, at least 18 years of age;
• Able to comprehend and sign the Informed Consent prior to enrolment in the study.

You may not qualify if:

• Potential participants who meet the following criteria will NOT be eligible for the study:
• Aged \<18 years of age;
• Unwilling or unable to provide informed consent;
• Previous surgery or trauma to the affected area.

Sponsors & Collaborators

• IntelligentUltrasound Limited: lead

Study Sites (1)

Intelligent Ultrasound Limited

Cardiff, Wales, CF10 1DY, United Kingdom

Location

Study Officials

• James Bowness

  Clinical consultant, University of Oxford & Royal Gwent Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 5, 2021
• Study Start: February 8, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)