Vaginal Infection
Conditions
Keywords
PH, SCREENING, EARLY WARNING, VAGINAL HEALTH, VAGINAL SECRETION, VAGINAL PH
Brief summary
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
Detailed description
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.
Interventions
DEVICENORMA-SENSE
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.
Sponsors
Common Sense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women, age 18 years or greater with or without symptoms of vaginal infection. 2. Subject is ready to sign the informed consent form.
Exclusion criteria
1. Subject is unable or unwilling to cooperate with study procedures. 2. Subject is currently participating in another clinical study. 3. Subject suffers from vaginal bleeding or is menstruating. 4. Subject that have had sexual relations within the last 12 hours. 5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days. 6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| color status of the NORMA-SENSE gen 3 and the pH measurement. | 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical comfort in using NORMA-SENSE gen 3 and the result reading clarity | 3 days | 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. |
Countries
Israel
Outcome results
None listed