Evaluation of the LVivo Image Quality Scoring (IQS)

September 28, 2022 updated by: DiA Imaging Analysis Ltd

The study includes two parts:

Part 1:

  • 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Each study includes 10 clips that represent typical user scanning errors
  • Offline evaluation of the system (by batch processing) shall be performed by comparing the system output to preliminary quality tagging by experienced sonographers

Part 2:

  • Live scans of apical 4CH clips of patients with indication for POCUS examination will be performed by POC physicians
  • LVivo IQS shall be used (on Lumify) during the scan for patients that meet inclusion criteria until 50 exams will be collected. 3 sec of each scan shall be saved, and Image quality score (IQS) shall be documented
  • Saved scans shall be reviewed by an expert physician to determine whether they are clinically interpretable

Study Overview

Status

Completed

Conditions

Detailed Description

Part 1 Total of 424 examination were collected from two medical centers. Participants that were referred to routine echo examinations and signed an informed consent were enrolled to the study. The image acquisition was done using ultrasound devices available in the medical centers. In addition Lumify ultrasound device was supplied by the sponsor.

Each examination contained 10 clips, each representing a different scanning scenario where the image acquisition contained transitions between common user "acquisition error" to correctly acquired images.

The examinations in DICOM format and echo reports were collected after anonymization, the patient details were documented in a study log that was stored in the medical center.

The collected clips were tagged for image quality by experienced sonographers. The distribution of the collected data according to ultrasound devices, age, gender and LV function was analyzed.

The data was randomly split into training and clinical validation sets, such that the proportion of data according to data distribution was maintained and the data set for the clinical evaluation will contain 100 patient examinations.

The LVivo IQS algorithm will be applied to the clinical validation set automatically by batch processing. The image quality score provided by the LVivo IQS will be compared to the image quality tagging by the sonographers

Part 2 The trial is designed as a prospective multicenter study, enrolling 50 patients at two medical centers. In each medical center Lumify ultrasound devices on which the LVivo IQS demo software will be installed will be provided for image acquisition. The image acquisition will be done by POC medical doctors, at different stages of their internship, that received POCUS training during their medical studies and are using ultrasound devices in accordance with their routine workflow. The scans will be done in different POC units including ER, ICU and internal departments.

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Soroka University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Part 1 Patients age ≥18 referred for echo evaluation

Part 2 Patients age ≥18 with indication for POCUS examination

Description

Inclusion Criteria:

Part 1 Study:

  1. Age ≥18
  2. Referred to routine Echo examination

Part 2 Study:

  1. Age ≥18
  2. Indication for POCUS

Exclusion Criteria:

Part 1 Study:

1. Subjects who fail to meet any inclusion criteria

Part 2 Study:

  1. Subjects who fail to meet any inclusion criteria
  2. Image quality 1-2 according to ACEP June 2018 [11]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Overall agreement of 75% between image quality classification by LVivo IQS and the data tagging by experienced sonographers
Time Frame: Up to 24 weeks
Up to 24 weeks
Part 2: 80% of the Exams with image quality 3-5 by visual estimation, received at least "Medium" image quality by LVivo IQS
Time Frame: Up to 24 weeks
Up to 24 weeks
Part 2: 90% of these cases (when at least "Medium" image quality is indicated by LVivo IQS) are clinically interpretable
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiA Imaging Analysis Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2022

Primary Completion (ACTUAL)

September 13, 2022

Study Completion (ACTUAL)

September 13, 2022

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

October 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR2P0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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