NCT03178825

Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sciton · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Vaginal Atrophy
• Sexual Dysfunction
• Dyspareunia
• Vaginal Dryness
• Chronic UTI

Interventions

Type	Name	Description
DEVICE	Hybrid Fractional Laser	Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Timeline

• Start date: 2017-05-19
• Primary completion: 2020-02-25
• Completion: 2020-02-25
• First posted: 2017-06-07
• Last updated: 2020-08-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study