UnknownNot Applicable

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.

United States, Mexico100 participantsStarted 2024-04-25

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

Intrauterine pathology detection rate with Hydrosonography

Timeframe: Procedure of 2-5 minute duration

Intrauterine pathology detection rate with Visual Saline Infusion

Timeframe: Procedure of approximately 2-5 minute duration

Trial details

NCT IDNCT06394752

SponsorCenter for Reproductive Health & Gynecology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

Contact for this trial

Alexander Nadal, MBA

323-420-6343 nadalalex@berkeley.edu

View on ClinicalTrials.gov More Hysteroscopy trials