Hydrosonography vs. Visual Saline InfusionUTERINE 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.

Visual Saline Infusion is intended to perform direct visual evaluation of the intrauterine space using a 2.7mm, steerable tip catheter with a camera.

Hydrosonography is the standard of care for intrauterine evaluation. 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 detect intrauterine pathology.

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.