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.

Last updated: April 30, 2024
Sponsor: Center for Reproductive Health & Gynecology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Infertility

Treatment

Visual Saline Infusion

Hydrosonography

Clinical Study ID

NCT06394752
TD-1033
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Visual Saline Infusion
Phase:
Study Start date:
April 25, 2024
Estimated Completion Date:
July 30, 2025

Study 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.

Connect with a study center

  • Punta Mita Fertility Center

    Corral Del Risco, Nayarit 63734
    Mexico

    Site Not Available

  • Center for Reproductive Health & Gynecology

    Beverly Hills, California 90007
    United States

    Active - Recruiting

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