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Procedure

Hydrosonography vs Visual Saline Infusion for Uterine Abnormalities

N/A

Recruiting

Led By Sam Najmabadi, MD

Research Sponsored by Center for Reproductive Health & Gynecology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal women between ages of 18-45

Patients requiring a uterine cavity evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up captured during procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the accuracy of a new device called Visual Saline Infusion Device (VSI) with the standard method, Hydrosonography, in identifying uterine problems in women of

Who is the study for?

This trial is for women of reproductive age who may have uterine abnormalities affecting fertility. Participants should not be currently pregnant, and must be willing to undergo diagnostic procedures to examine the inside of their uterus.

What is being tested?

The study is comparing two methods used to detect problems inside the uterus: a new device that allows doctors to see directly into the uterus with saline infusion (VSI), versus the usual method using sound waves in water (Hydrosonography).

What are the potential side effects?

Potential side effects from these procedures could include discomfort or pain during insertion, cramping similar to menstrual cramps, light vaginal bleeding, and less commonly infection or injury to the uterus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18-45 and have not gone through menopause.

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I need a check-up of the inside of my uterus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure of 2-5 minute duration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure of 2-5 minute duration

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure of 2-5 minute duration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intrauterine pathology detection rate with Hydrosonography

Intrauterine pathology detection rate with Visual Saline Infusion

Secondary study objectives

Adverse events rate

Fluid used during distention

Pain during procedure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Visual Saline InfusionExperimental Treatment1 Intervention

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

Group II: HydrosonographyActive Control1 Intervention

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.

0 / 2Eligibility criteria met