NCT01542606

Performance Proof of Product Developed to Detect Abnormal Vaginal pH

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Common Sense · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Infection

Interventions

Type	Name	Description
DEVICE	NORMA-SENSE	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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2012-03-02
• Last updated: 2019-10-31

Locations

1 site across 1 country: Israel