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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrophy, Vaginal Atrophy, Genital Diseases, Female

Intervention / Treatment
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* Procedure: Pixel CO2 Laser System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: treatment<br>only one arm | Procedure: Pixel CO2 Laser System<br> <br> * Other names: FemiLift;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vulvovaginal Atrophy (VVA) | Utilizing Bachman Vaginal Health Index | 6 months |