Performance Proof of the New NORMA-SENSE
- Conditions
- Vaginal Infection
- Interventions
- Device: NORMA-SENSE
- Registration Number
- NCT00802763
- Lead Sponsor
- Carmel Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 224
Inclusion Criteria
- Women, age 18 years or greater 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description vaginitis NORMA-SENSE -
- Primary Outcome Measures
Name Time Method 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. 1 week
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lin Medical center
🇮🇱Haifa, Israel