Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy

Launched by HILLEL YAFFE MEDICAL CENTER · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Pixel CO2 Laser (FemiLift™) for women experiencing vulvo-vaginal atrophy (VVA), a condition often caused by menopause. VVA leads to thinning and drying of the vaginal and vulvar tissues due to lower estrogen levels, which can cause symptoms like dryness, irritation, pain during sex, and discomfort while urinating. The laser treatment aims to help restore the vaginal tissues to a healthier, more youthful state by encouraging natural healing and tissue regeneration.

Women between the ages of 45 and 75 who have gone through menopause and are experiencing one or more symptoms of VVA may be eligible to join the study. To take part, participants should have had no recent infections or serious health issues that could affect healing, and they must be willing to follow the treatment and check-up schedule. If you join, you can expect to receive laser therapy aimed at improving the condition of your vaginal tissues, with the goal of reducing symptoms and improving comfort. This trial is currently recruiting, so if you think this might be a good fit for you, discussing it with your healthcare provider could be a helpful next step.

Gender

FEMALE

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 Health Index Score (VHIS) \< 5.
• • 2. Active genital infection.
• • 3. Vaginal bleeding which did not underwent evaluation.
• • 4. Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
• • 5. Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
• • 6. Pelvic Organ prolapse (POP) \>II, according to the pelvic organ prolapse quantification system (POP-Q).
• • 7. Serious systemic disease or any chronic condition that could interfere with study compliance.
• • 8. Any local, systemic and/or chronic autoimmune infection.
• • 9. Taken part in a clinical trial concerning VVA, within 30 days prior to the enrolment.
• • 10. Allergy to lidocaine or tetracaine.
• • 11. Genital skin disease that may interfere with the treatment (these subjects should be included/excluded according to the investigator's discretion).
• • 12. Use of anticoagulants, within 5 days prior to enrolment.
• • 13. Active positive HPV test.
• • 14. Active positive HSV (Acute or actively present within the last 2 months).
• • 15. Heavy smoker (\>1 pack of cigarettes a day)
• • 16. Any disease or medication that may interfere with the wound healing/immune function.
• • 17. Pregnancy / breast feeding.
• • 18. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.