NCT06394752

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.

UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Center for Reproductive Health & Gynecology · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Visual Saline Infusion	Visual Saline Infusion (VSI) is a new intrauterine imaging procedure to identify uterine pathology. The VSI 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).
DEVICE	Hydrosonography	Hydrosonography is an ultrasound based intrauterine imaging technique with sensitivity and specificity ranging from 90% to 100% for identifying uterine pathology. It is performed by inserting a slim 2 mm catheter into the uterine cavity and infusing saline solution to expand the uterus and using abdominal ultrasound to visualize the uterus.

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-05-01
• Completion: 2025-07-30
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

2 sites across 2 countries: United States, Mexico

Regulatory

• FDA-regulated device study