OB-GYN Clinical Validation Study

Completed · Not applicable

Conditions studied: Obstetric Complication, GYN Disorders

In brief

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

Key facts

Study ID

NCT06449872

Run by

EchoNous Inc.

People needed

44

Starts

2023-10-24

Expected to finish

2024-04-30

Last updated by the study team

2024-06-10

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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