Pixel CO2 (FemiLift) laser treatment for vulvo-vaginal atrophy

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

This trial tests whether the Pixel CO2 (FemiLift) laser can relieve symptoms and restore healthier vaginal tissue in postmenopausal women with vulvo-vaginal atrophy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 45 Years to 75 Years
• Sex: Female
• Sponsor: Hillel Yaffe Medical Center (Government)
• Locations: 1 site (Hadera)
• Trial ID: NCT07024667 on ClinicalTrials.gov

What this trial studies

This single-center interventional trial at Hillel Yaffe Medical Center enrolls postmenopausal women aged 45–75 with symptomatic vulvo-vaginal atrophy and no active vaginal infection. Participants receive treatments with the Pixel fractional CO2 (FemiLift) laser and are followed for clinical symptom changes and safety. The study includes molecular and histologic assessments of vaginal tissue such as epithelial thickness, collagen content, glycogen levels, fibroblast density, and vascularity to document tissue regeneration. Standard screening (PAP, urine testing) and gynecological exams are used to confirm eligibility and monitor adverse events.

Who should consider this trial

Good fit: Postmenopausal women aged 45–75 with clinical and exam evidence of vulvo-vaginal atrophy, negative tests for active vaginitis, and ability to attend follow-up visits are ideal candidates.

Not a fit: Women with active bacterial or fungal vaginitis, vaginal injuries or bleeding, abnormal recent gynecological exams, or those outside the specified age/menopause criteria are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, treatment could reduce dryness, pain, and other VVA symptoms and partially restore premenopausal tissue features.

How similar studies have performed: Smaller studies of fractional CO2 vaginal lasers have reported histologic tissue regeneration and symptom improvement, but long-term benefit and randomized evidence remain limited.

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.

Where this trial is running

Hadera

• Hille Yaffe Medical Center — Hadera, Israel (Recruiting)

Study contacts

• Principal investigator: Jonia Alsheik, MD — Hillel Yaffe Medical Center
• Study coordinator: Jonia Alsheik, MD

Conditions Vulvar Atrophy; Vaginal Atrophy