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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.
Sponsor: Center for Reproductive Health & Gynecology
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.
Official title: UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
Key Details
Gender
FEMALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-04-25
Completion Date
2025-07-30
Last Updated
2024-05-01
Healthy Volunteers
Yes
Conditions
Interventions
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).
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.
Locations (2)
Center for Reproductive Health & Gynecology
Beverly Hills, California, United States
Punta Mita Fertility Center
Corral Del Risco, Nayarit, Mexico