NCT03956563

Effect of Hybrid Laser 10600+1540 nm on GSM

Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Quanta System, S.p.A. · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are: 1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months. 2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment. 3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment * For the GSM symptoms * For the urinary symptoms and UI 4. To assess the patient's satisfaction with the laser treatment. * For the GSM symptoms * For the urinary symptoms and UI.

Conditions

• Vaginal Atrophy
• Genitourinary Disease

Interventions

Type	Name	Description
DEVICE	Youlaser MT Group 2	Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the control arm will receive 3 simulated laser treatments every 30 days. A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject.
DEVICE	Youlaser MT Group 1	Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days.

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-05-15
• Completion: 2020-08-15
• First posted: 2019-05-20
• Last updated: 2019-05-20

Locations

1 site across 1 country: Spain