NCT00802763

Performance Proof of the New NORMA-SENSE

Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 224 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-12-05
• Last updated: 2008-12-05

Locations

1 site across 1 country: Israel