Performance Proof of the New NORMA-SENSE
NCT00802763 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 224
Last updated 2008-12-05
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.
Conditions
- Vaginal Infection
Interventions
- DEVICE
-
NORMA-SENSE
Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.
Sponsors & Collaborators
-
Carmel Medical Center
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2009-07-31
- Completion
- 2009-08-31
Countries
- Israel
Study Locations
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