OB-GYN Clinical Validation Study

June 6, 2024 updated by: EchoNous Inc.

ECHO-007 OB-GYN Clinical Validation Study

This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Six healthcare professionals with training and experience in Obstetrics and Gynecology ultrasound qualitatively assessed the image quality of the Kosmos Diagnostic Ultrasound System compared to the benchmark Mindray M9 Ultrasound System. Five sonographers were required to complete each scanning cohort of at least three gravid and three non-gravid participants. A sixth sonographer was added to the study to accommodate a scheduling conflict and provided additional image quality data outside of the five completed cohorts.

The following views/structures were assessed for image quality:

Gynecology participants:

  • Uterus
  • Ovaries
  • Endometrial cavity

  • Cervix

    • Obstetrics participants in their 1st trimester:

  • General image quality of the fetus
  • Ability to visualize the crown rump length
  • Visualization of gestational sac

  • Visualization of yolk sac if present

    • Obstetrics and participants in their 2nd trimester:

  • General image quality of the fetal structures
  • Visualization of the amniotic fluid
  • Visualization of the placenta
  • Cardiac motion in 2D and M-mode with heart rate

Obstetrics and participants in their 3rd trimester:

  • General image quality of the fetal structures
  • Visualization of the amniotic fluid
  • Visualization of the placenta
  • Visualization of the maternal cervix
  • Cardiac motion in 2D and M-mode with heart rate
  • 3 vessel umbilical cord in 2D and Color Doppler The sonographers captured all views/structures on the Mindray M9 Ultrasound System, then switched over to the Kosmos Diagnostic Ultrasound System to capture the same views/structures. Once all views/structures were captured on both ultrasound systems, the healthcare professionals reviewed the images in parallel on each system, then provided a comparison score for Kosmos between 1 and 7.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

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

  • United States
    • Washington
      • Redmond, Washington, United States, 98052
        • EchoNous, Inc.

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Persons able to:

    1. Read and sign an English consent form.
    2. Read and complete an English demographic and general health survey.
    3. Give consent for participation.
    4. Able and willing to comply with study requirements.
  2. Those aged 18 years through 40 years, healthy, particularly in respect to their pregnancy.
  3. Pregnant individuals who have received a previous ultrasound exam by their physician.

Exclusion Criteria:

  1. Children (minors) under 18 years old.
  2. Adults over 40 years old.
  3. Those who cannot or refuse to sign their consent.
  4. Those who cannot provide informed consent.
  5. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation.
  6. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by parents, employer or monetary benefit.
  7. Pregnant individuals who have not received a previous ultrasound exam by their physician.
  8. Individuals who have had a hysterectomy, oophorectomy, and trachelectomy.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Comparison scanning protocol for OB and GYN clinical applications
Image quality comparative assessment
Device: Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
Up to 5 healthcare professionals trained and experienced in Obstetrics and Gynaecology ultrasound qualitatively assessed the diagnostic image quality of the Kosmos Diagnostic Ultrasound System against the benchmark Mindray M9 Ultrasound System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Ultrasound Image Quality Score
Time Frame: Through study completion, up to 1 month
Qualitative image assessment of required views/structures generated with Kosmos Diagnostic Ultrasound System versus a cart-based ultrasound system.
Through study completion, up to 1 month

Collaborators and Investigators

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

Sponsor

EchoNous Inc.

Investigators

  • Principal Investigator: Robert Blankenship, MD, Mercy West Hospital

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)

October 24, 2023

Primary Completion (Actual)

November 29, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECHO-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Obstetric Complication

Clinical Trials on Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe