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UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
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.
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.
Age
18 - 55 years
Sex
FEMALE
Healthy Volunteers
Yes
Center for Reproductive Health & Gynecology
Beverly Hills, California, United States
Punta Mita Fertility Center
Corral Del Risco, Nayarit, Mexico
Start Date
April 25, 2024
Primary Completion Date
May 1, 2025
Completion Date
July 30, 2025
Last Updated
May 1, 2024
100
ESTIMATED participants
Visual Saline Infusion
DEVICE
Hydrosonography
DEVICE
Lead Sponsor
Center for Reproductive Health & Gynecology
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06637111