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OpenTrials
Completed

NCT Number: NCT04830891

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

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.

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Key information

Conditions

Ultrasound Imaging of Anatomical Structures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intelligent Ultrasound Limited

Cardiff, Wales, CF10 1DY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Change in per-class Mean Intersection over Union (IoU) scores of deep-learning segmentation models compared to baseline models

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IntelligentUltrasound Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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