Actively Recruiting
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy (VVA)
Led by Hillel Yaffe Medical Center · Updated on 2025-06-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Vulvo Vaginal Atrophy (VVA) is a condition affecting the vaginal and vulvar areas during menopause due to decreasing estrogen levels, causing symptoms such as dryness, irritation, soreness, pain during sex, painful urination, and discharge. This trial investigates the effects of a fractional microablative CO2 laser treatment called Pixel CO2 Laser (FemiLiftTM) to assess its impact on clinical symptoms and molecular changes in the vaginal tissue. Participants will receive treatment with the Pixel CO2 Laser device aimed at regenerating the vaginal epithelium and connective tissues. The laser treatment is designed to restore the vaginal lining to a state resembling that before menopause, indicated by thicker epithelium, increased collagen, glycogen, fibroblasts, vascularity, and other tissue improvements. The study focuses on evaluating these effects over a two-year period. During the study, researchers will monitor patient symptoms and complaints related to VVA and evaluate gene expression changes following treatment. Assessments will include gynecological exams, symptom tracking, and laboratory tests such as urine analysis and Pap smears as needed. Participants will be followed for two years to observe outcomes and safety while adhering to the treatment and follow-up schedules.
CONDITIONS
Brief 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 the time of enrollment
- Provided written informed consent
- Menopause defined by amenorrhea for 12 months or more, bilateral oophorectomy, or FSH levels above 30 IU
- Presence of one or more vulvo-vaginal atrophy symptoms such as itching, dryness, burning, pain, dyspareunia, or dysuria after excluding other causes
- Characteristic atrophic changes confirmed by gynecological exam
- Normal Pap smear test within last 3 to 5 years if indicated
- Negative urine analysis test
- No symptoms of bacterial or fungal vaginitis
- Vaginal canal, introitus, and vestibule free of injuries and bleeding
- Able and willing to follow treatment and follow-up schedule
- Normal general gynecological exam including ultrasound within the past year
You will not qualify if you...
- Vaginal Health Index Score below 5
- Active genital infection
- Vaginal bleeding without evaluation
- History of vulvar, vaginal, or cervical dysplasia within last 2 years or previous cancer
- Recurring urinary tract or genital herpes infections (3 or more episodes in past year)
- Pelvic organ prolapse greater than grade II
- Serious systemic or chronic conditions interfering with study compliance
- Local, systemic, or chronic autoimmune infections
- Participation in another VVA clinical trial within 30 days prior to enrollment
- Allergy to lidocaine or tetracaine
- Genital skin diseases that interfere with treatment
- Use of anticoagulants within 5 days prior to enrollment
- Positive active HPV or HSV test
- Heavy smoking (more than 1 pack per day)
- Diseases or medications affecting wound healing or immune function
- Pregnancy or breastfeeding
- Any condition or reason judged by investigator to prevent participation or compromise safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive treatment with the Pixel CO2 Laser (FemiLiftTM) for vulvo-vaginal atrophy.
Visit schedule not specified
Duration - Up to 2 years
Participants are monitored for up to two years to evaluate treatment efficacy and gene expression changes.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Hille Yaffe Medical Center
Hadera, Israel, 3881000
Actively Recruiting
Research Team
J
Jonia Alsheik, MD
O
Osnat Palgi mirochnik, RN, BSc
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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