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.

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.

Conditions

Hysteroscopy, Hysteroscopy Technique, Fertility Issues, Uterus Abnormal, Gynecology, Visualization, Infertility Female

Study Overview

Study Details

Study 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.

UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY

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.

Condition
Hysteroscopy
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Center for Reproductive Health & Gynecology, Beverly Hills, California, United States, 90007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients requiring a uterine cavity evaluation
  • 2. Premenopausal women between ages of 18-45
  • 1. Positive test or history of any of the following conditions:

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Center for Reproductive Health & Gynecology,

Sam Najmabadi, MD, PRINCIPAL_INVESTIGATOR, Center for Reproductive Health & Gynecology

Study Record Dates

2025-07-30