NCT07024667 Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
| NCT ID | NCT07024667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hillel Yaffe Medical Center |
| Condition | Vulvar Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-02 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Female 45-75 years of age, at the time of enrolment. 2. Provided written informed consent. 3. Spontaneous induced menopause as defined by one of the followings: * Amenorrhea of ≥12 months * After bilateral oophorectomy * FSH levels\>30 IU 4. One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded. 5. Characteristic atrophic changes (see above) on gynaecological examination. 6. Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines. 7. Negative urine analysis test - urine stick. 8. Asymptomatic for bacterial or fungal vaginitis. 9. Vaginal canal, introitus and vestibule free of injuries and bleeding. 10. Able and willing to comply with the treatment/ follow-up schedule and requirements. 11. Normal general gynecological exam from the last year including US. Exclusion Criteria: 1. Vaginal