Performance Proof of Product Developed to Detect Abnormal Vaginal pH

Study Overview
=================
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.

Official Title
-----------------
Performance Proof of The Norma-Sense Gen 3 - Wearing Study

Conditions
-----------------
Vaginal Infection

Intervention / Treatment
-----------------
* Device: NORMA-SENSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, age 18 years or greater with or without symptoms of vaginal infection. Subject is ready to sign the informed consent form. Exclusion Criteria: Subject is unable or unwilling to cooperate with study procedures. Subject is currently participating in another clinical study. Subject suffers from vaginal bleeding or is menstruating. Subject that have had sexual relations within the last 12 hours. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: color status<br>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. | Device: NORMA-SENSE<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCREENING, EARLY WARNING, VAGINAL HEALTH, VAGINAL SECRETION, VAGINAL PH, PH