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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2022-04-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ultrasound Imaging of Anatomical Structures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes