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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLiftâ„¢ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Other | only one arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pixel CO2 Laser System | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vulvovaginal Atrophy (VVA) | Utilizing Bachman Vaginal Health Index | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Weston | Florida | 33331 | United States |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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