NCT02747641

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Alma Lasers Inc. · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

Conditions

• Atrophy
• Vaginal Atrophy
• Genital Diseases, Female

Interventions

Type	Name	Description
PROCEDURE	Pixel CO2 Laser System

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-01
• Completion: 2017-08-01
• First posted: 2016-04-22
• Last updated: 2017-11-21

Locations

1 site across 1 country: United States