Overview

This trial is active, not recruiting.

Conditions atrophy, vaginal atrophy, genital diseases, female
Treatment pixel co2 laser system
Phase phase 0
Sponsor Alma Lasers Inc.
Collaborator The Cleveland Clinic
Start date May 2016
End date November 2016
Trial size 15 participants
Trial identifier NCT02747641, FLA 15-110

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
only one arm
pixel co2 laser system FemiLift

Primary Outcomes

Measure
Vulvovaginal Atrophy (VVA)
time frame: 6 months

Eligibility Criteria

Female participants from 35 years up to 70 years old.

Inclusion Criteria: - Healthy, non-smoking - Woman, age 35 to 70 yrs, menopausal - Provided written Informed Consent - Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.) - Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system - Normal PAP smear (up to 1 year prior to baseline) - Vaginal canal, introitus and vestibule free of injuries and bleeding - Have not had procedures in the anatomical area through 6 months prior to treatment - Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits Exclusion Criteria: - Severe prolapse (POP>= grade 3) - Use of photosensitive drugs - Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida). - Any serious disease, or chronic condition, that could interfere with the study compliance - Acute or actively present within the last 2 months HPV/HSV - Undiagnosed vaginal bleeding - Urge or overflow incontinence - Patients who are on antidepressants, or α-adrenergic and anticholinergic medications - Patients with immune system diseases. - Patients with allergic reaction to laser. - Obese women (BMI >30) - Patient unable to follow post-treatment instructions - History of keloid formation - Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment - A history of thrombophlebitis - A history of acute infections - A history of heart failure - Previously undergone reconstructive pelvic surgery - Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months - Any medical condition that in the investigators opinion would interfere with the patients participation in the study

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Alma Lasers Inc..