UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY. This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography, and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus.

Status unconfirmed · Not applicable

Conditions studied: Hysteroscopy, Hysteroscopy Technique, Fertility Issues, Uterus Abnormal, Gynecology, Visualization, Infertility Female

In brief

This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.

Key facts

Study ID

NCT06394752

Run by

Center for Reproductive Health & Gynecology

People needed

100

Starts

2024-04-25

Expected to finish

2025-07-30

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Patients requiring a uterine cavity evaluation
• Premenopausal women between ages of 18-45

You may not qualify if…

• Positive test or history of any of the following conditions:
• 1a. Chlamydial pelvic infection
• 1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place

Where it is running

• Center for Reproductive Health & Gynecology — Beverly Hills, California, United States (enrolling)
• Punta Mita Fertility Center — Corral del Risco, Nayarit, Mexico

Full record on ClinicalTrials.gov

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