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Internal decision of the sponsor
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This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level
This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| color status | Experimental | The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NORMA-SENSE | Device | The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test. |
| Measure | Description | Time Frame |
|---|---|---|
| color status of the NORMA-SENSE gen 3 and the pH measurement. | agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| physical comfort in using NORMA-SENSE gen 3 and the result reading clarity | the patient report regarding physical comfort in using NORMA-SENSE gen 3 and the result reading clarity including the ability to visualize and interpret the NORMA-SENSE gen 3 results. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Kessary, PhD | Common Sense | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lin Medical Center Clalit health care | Haifa | Israel |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |