Actively Recruiting
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
Led by Hillel Yaffe Medical Center · Updated on 2025-06-17
20
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge. In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
CONDITIONS
Official Title
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 45 to 75 years at enrollment
- Provided written informed consent
- Menopause confirmed by amenorrhea for 12 months or more, after removal of both ovaries, or FSH levels above 30 IU
- Experiencing one or more symptoms of VVA such as itching, dryness, burning, pain, pain during intercourse, or painful urination after excluding other causes
- Atrophic changes visible on gynecological exam
- Normal Papanicolaou smear test within the last 3 to 5 years if indicated
- Negative urine test
- No symptoms of bacterial or fungal vaginitis
- Vaginal canal, opening, and surrounding area free of injuries or bleeding
- Willing and able to follow treatment and study schedule
- Normal general gynecological exam including ultrasound within the last year
You will not qualify if you...
- Vaginal Health Index Score less than 5
- Active genital infection
- Vaginal bleeding not evaluated
- History of vulvar, vaginal, or cervical dysplasia in the last 2 years or any previous cancer
- Recurrent urinary tract infections or genital herpes infections (3 or more episodes in the past year)
- Pelvic organ prolapse stage greater than II
- Serious systemic or chronic illness affecting study compliance
- Any local, systemic, or chronic autoimmune infections
- Participation in a VVA clinical trial within 30 days prior to enrollment
- Allergy to lidocaine or tetracaine
- Genital skin diseases that interfere with treatment as decided by the investigator
- Use of blood thinners within 5 days before enrollment
- Positive HPV test
- Active HSV infection currently or within the last 2 months
- Heavy smoking (more than 1 pack per day)
- Any disease or medication affecting wound healing or immune function
- Pregnant or breastfeeding
- Any other reason that may prevent safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hille Yaffe Medical Center
Hadera, Israel, 3881000
Actively Recruiting
Research Team
J
Jonia Alsheik, MD
CONTACT
O
Osnat Palgi mirochnik, RN, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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