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.

Fertility Issues Clinical Trial

Official title: UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

Patients who are enrolled in the study will have a 1) Hydrosonography, and 2) Visual Saline Infusion procedure performed.

The Visual Saline Infusion Device is a 2.7mm, steerable tip catheter with a camera and illumination at the distal end. The device is intended to evaluate the intrauterine space in an office based, outpatient setting using minimal volume of fluid (3-5cc's).

This study will recruit up to 100 women from a fertility center in Los Angeles. ;

Related Conditions & MeSH terms

• Fertility Issues
• Gynecology
• Hysteroscopy
• Hysteroscopy Technique
• Infertility
• Infertility Female
• Infertility, Female
• Uterus Abnormal

• NCT number: NCT06394752
• Study type: Interventional
• Source: Center for Reproductive Health & Gynecology
• Contact: Alexander Nadal, MBA
• Phone: 323-420-6343
• Email: nadalalex@berkeley.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Completion date: July 30, 2025