Study for the Assessment of USEG Software.

NCT05067803 | Completed

• 1 other identifier: USEG-101
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.). The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study.

• Images can be acquired manually by a novice user.
• Each novice user will have a training course of 8 hours, before the study commences.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• To assess the quality of clips obtained by novice users when using the USEG software.

  The expert cardiologists will evaluate whether the echo examination has sufficient to evaluate each of the primary endpoints: 1. Sufficient quality to assess Left Ventricular (LV) size: (YES/NO) 2. Sufficient quality to assess LV function: (Yes/No) 3. Sufficient quality to assess Right Ventricular size: (Yes/No) 4. Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)

  1 year.

Secondary Outcomes (2)

• Sufficient quality assessment for six (6) anatomic elements.

  1 year.

• Diagnostic quality assessment.

  1 year.

Other Outcomes (1)

• Safety outcome.

  1 year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 100 male and female adults confirmed as eligible according to eligibility criteria.

You may qualify if:

• Age 18 and older
• Subjects willing and able to give written informed consent.

You may not qualify if:

• Emergency (non-elective) admission within 24 h prior to participating in the study
• Female subjects who are pregnant (WOCBP\* will perform a urine pregnancy test)
• Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus.
• Subjects who currently participate a clinical trial, involving interventional cardiac devices
• Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
• Subjects with BMI above 40
• Subjects experiencing a known or suspected acute cardiac event
• Subjects with severe chest wall deformity as per previous medical records and physical examination
• Subjects who have undergone pneumonectomy
• Subjects whose anatomy does not lend itself to yield diagnosable echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.)
• A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.)

Sponsors & Collaborators

• UltraSight: lead

Study Sites (1)

Sheba MC

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Robert Klempfner, MD

  Sheba MC

  PRINCIPAL INVESTIGATOR

• Danny Spiegelstein, MD

  UltraSight

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: December 24, 2021
• Primary Completion: January 23, 2022
• Study Completion: January 23, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)