Performance Proof of the New NORMA-SENSE

Carmel Medical Center224 enrolled

Overview

This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with 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 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.

Study Type

OBSERVATIONAL

Enrollment

224

Conditions

Vaginal Infection

Interventions

NORMA-SENSEDEVICE

Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women, age 18 years or greater 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.

Locations (1)

Lin Medical center

Haifa, Israel

Outcomes

Primary Outcomes

We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.

Time frame: 1 week

Central Contacts

HADAR KESSARY, PhD

CONTACT

972-4-6277101 HADAR@CS-COMMONSENSE.COM

Data from ClinicalTrials.gov

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