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.
- 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
- 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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