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OB-GYN Clinical Validation Study

NCT06449872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-06-10

No results posted yet for this study

Summary

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

Conditions

  • Obstetric Complication
  • GYN Disorders

Interventions

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.

Sponsors & Collaborators

  • EchoNous Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Blankenship, MD · Mercy West Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2023-11-29
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449872 on ClinicalTrials.gov