## Protocol Section
### Identification Module
**NCT ID:** NCT04040179

**Brief Title:** A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide

**Official Title:** A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide

#### Organization Study ID Info
**ID:** IU2019_AG_03
#### Organization
**Class:** INDUSTRY
**Full Name:** Medaphor Limited
### Status Module
#### Completion Date
**Date:** 2019-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-10

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-08-05

**Type:** ACTUAL

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2019-07-31
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-30
**Study First Submit QC Date:** 2019-07-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** IntelligentUltrasound Limited

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Medaphor Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

**Detailed Description:** The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:

* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary
* ESP
* PECS
* Interscalene

Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.

The videos will be segmented by hand to identify the relevant anatomical regions for each category.

The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.

### Conditions Module

**Conditions:**

- Ultrasound Imaging of Anatomical Structures

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Models with a Mean intersection over Union score of 0.95 or better for each region in each category.

**Measure:** Model development

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:

   * Adductor canal
   * Popliteal fossa
   * Fascia Iliaca
   * Rectus sheath
   * Axillary
   * ESP
   * PECS
   * Interscalene
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy volunteers

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cardiff

**Country:** United Kingdom

**Facility:** Medicentre

**Zip:** CF14 4UJ

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
