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

Sponsor
IntelligentUltrasound Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04830891
Collaborator
(none)
100
Enrollment
1
Location
14.4
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Volunteer Study to Collect Imaging Data for the Development and Validation of Intelligent Ultrasound ScanNav Anatomy PNB
    Actual Study Start Date :
    Feb 8, 2021
    Actual Primary Completion Date :
    Apr 22, 2022
    Actual Study Completion Date :
    Apr 22, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Intelligent Ultrasound Limited Cardiff Wales United Kingdom CF10 1DY

    Sponsors and Collaborators

    • IntelligentUltrasound Limited

    Investigators

    • Principal Investigator: James Bowness, Clinical consultant, University of Oxford & Royal Gwent Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IntelligentUltrasound Limited
    ClinicalTrials.gov Identifier:
    NCT04830891
    Other Study ID Numbers:
    • IU2021_AG_05
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 5, 2022