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
Center for Reproductive Health & Gynecology
100 participants
Apr 25, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Patients requiring a uterine cavity evaluation
- Premenopausal women between ages of 18-45
Exclusion Criteria3
- \. Positive test or history of any of the following conditions:
- a. Chlamydial pelvic infection
- b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place
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Interventions
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 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)
View Full Details on ClinicalTrials.gov
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NCT06394752