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.

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

May 1, 2025

Study Completion Date

July 30, 2025

Conditions
HysteroscopyHysteroscopy TechniqueFertility IssuesUterus AbnormalGynecologyVisualizationInfertility Female
Interventions
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.

Trial Locations (2)

63734

NOT_YET_RECRUITING

Punta Mita Fertility Center, Corral Del Risco

90007

RECRUITING

Center for Reproductive Health & Gynecology, Beverly Hills

Sponsors
All Listed Sponsors
collaborator

Butterfly Biosciences, Inc

UNKNOWN

lead

Center for Reproductive Health & Gynecology

OTHER