UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hysteroscopy
- Sponsor
- Center for Reproductive Health & Gynecology
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Intrauterine pathology detection rate with Visual Saline Infusion
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients requiring a uterine cavity evaluation
- •Premenopausal women between ages of 18-45
Exclusion Criteria
- •Positive test or history of any of the following conditions:
- •1a. Chlamydial pelvic infection
- •1b. Gonorrheal pelvic infection.
- •Positive Pregnancy Test
- •IUD currently in place
Outcomes
Primary Outcomes
Intrauterine pathology detection rate with Visual Saline Infusion
Time Frame: Procedure of approximately 2-5 minute duration
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.
Intrauterine pathology detection rate with Hydrosonography
Time Frame: Procedure of 2-5 minute duration
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.
Secondary Outcomes
- Visual detection quality score (1-10)(Captured during procedure)
- Pain during procedure(Collected on day of procedure)
- Fluid used during distention(Captured during procedure)
- Adverse events rate(Day of procedure and 24-48 hours post to procedure)