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 & Gynecology100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Hysteroscopy Hysteroscopy Technique Fertility Issues

Interventions

Visual Saline InfusionDEVICE

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).

HydrosonographyDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intrauterine pathology detection rate with Hydrosonography

The assessment will involve the examination of the intrauterine cavity for the presence of pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.

Time frame: Procedure of 2-5 minute duration

Intrauterine pathology detection rate with Visual Saline Infusion

The assessment will involve the examination of the intrauterine cavity for the presence of known pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.

Time frame: Procedure of approximately 2-5 minute duration

Secondary Outcomes

Visual detection quality score (1-10)

The visual detection quality score will be assessed using a normalized scale ranging from 1 (indicating poor or no visualization) to 10 (indicating excellent visualization), with scores assigned based on the clarity and detail of the intrauterine images obtained during the examination.

Time frame: Captured during procedure

Fluid used during distention

The volume of fluid used for distention of the uterus will be documented.

Time frame: Captured during procedure

Pain during procedure

The research team will interview the Subject and record the level of pain experienced based on the Wong Baker pain scale

Time frame: Collected on day of procedure

Adverse events rate

Anticipated and unanticipated adverse events will be documented

Time frame: Day of procedure and 24-48 hours post to procedure