OB-GYN Clinical Validation Study

NCT06449872 | Completed FDA Device

• 1 other identifier: ECHO-007
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstetric Complication; GYN Disorders

Outcome Measures

Primary Outcomes (1)

• Average Ultrasound Image Quality Score

  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

Study Arms (1)

Comparison scanning protocol for OB and GYN clinical applications

OTHER

Image quality comparative assessment

Device: Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems

Interventions

Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems DEVICE

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.

Comparison scanning protocol for OB and GYN clinical applications

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Children (minors) under 18 years old.
• Adults over 40 years old.
• Those who cannot or refuse to sign their consent.
• Those who cannot provide informed consent.
• 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.
• Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by parents, employer or monetary benefit.
• Pregnant individuals who have not received a previous ultrasound exam by their physician.
• Individuals who have had a hysterectomy, oophorectomy, and trachelectomy.

Sponsors & Collaborators

• EchoNous Inc.: lead

Study Sites (1)

EchoNous, Inc.

Redmond, Washington, 98052, United States

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Robert Blankenship, MD

  Mercy West Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 10, 2024
• Study Start: October 24, 2023
• Primary Completion: November 29, 2023
• Study Completion: April 30, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)