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| Name | Class |
|---|---|
| Key2Compliance | INDUSTRY |
| Replior AB | UNKNOWN |
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This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material.
The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One dose daily for 7 consequtive days (dose acc to IFU) | Other | Open user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D005 vaginal mousse | Device | D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate symptom relief during treatment with Vernivia®. | Evaluation of number of days from start of treatment until symptom relief | 1-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported grading of malodorous discharge (0-3) | Evaluate how the user experiences the product with regards to malodorous (1 = Not likely, 10 = Very likely) | 1-7 days |
| Net Promotor Score regarding user-friendliness |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mama Mia Väla | Väla | Helsingborg | 25467 | Sweden | ||
| Mednika AB |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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|
Evaluate how the user experiences the user-friendliness
(1 = Not likely, 10 = Very likely)
| 1-7 days |
| Clarity of the IFU (Instructions For Use) | Evaluate how the user experiences the IFU (Instructions For Use) (1= Not at all informative, 5= Very informative) | 1-7 days |
| Clarity of instructional video | Evaluate how the user experiences the instructional video (1= Not at all informative, 5= Very informative) | 1-7 days |
| Linköping |
| 58758 |
| Sweden |
| Hälsomedicinskt Center | Lomma | 23439 | Sweden |
| Mama Mia Barnmorskemottagning | Malmö | 21141 | Sweden |
| Kvinnohälsan Stadsfjärden | Nyköping | 61131 | Sweden |
| 2Heal Medical | Stockholm | 11435 | Sweden |
| Ondrasek Läkarmottagning | Sundsvall | 85230 | Sweden |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |