Last updated on August 2018

Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause


Brief description of study

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.

Detailed Study Description

Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.

Clinical Study Identifier: NCT03178825

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Peter Castillo, MD

Women's Pelvic Health Institute
Los Gatos, CA United States

Michael Coyle, DO

Coyle Institute
Pensacola, FL United States

Kevin Stepp, MD

Carolinas Healthcare System
Charlotte, NC United States

John J Peet, MD

Woodlands Gynecology & Aesthetics
The Woodlands, TX United States

Nathan Guerette, MD

The Female Pelvic Medicine Institute of Virginia
North Chesterfield, VA United States