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.

Center for Reproductive Health & Gynecology

Status: Enrolling

Conditions: Uterus Abnormal; Visualization; Hysteroscopy Technique; Infertility Female; Hysteroscopy; Gynecology; Fertility Issues

Treatments: Device: Hydrosonography; Device: Visual Saline Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06394752

TD-1033

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients requiring a uterine cavity evaluation
2. Premenopausal women between ages of 18-45

Exclusion criteria

1. Positive test or history of any of the following conditions:

1a. Chlamydial pelvic infection

1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Visual Saline Infusion

Experimental group

Description:

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

Treatment:

Device: Visual Saline Infusion

Hydrosonography

Active Comparator group

Description:

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.

Treatment:

Device: Hydrosonography