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Effect of Hybrid Laser 10600+1540 nm on GSM

NCT03956563 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Quanta System, S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2020-05-15
Completion
2020-08-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956563 on ClinicalTrials.gov