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
This trial is active, not recruiting.
|Conditions||atrophy, vaginal atrophy, genital diseases, female|
|Treatment||pixel co2 laser system|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
only one arm
Vulvovaginal Atrophy (VVA)
time frame: 6 months
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
|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|
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