Performance Proof of the New NORMA-SENSE

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00802763
• Other study ID #: F-7-28.1-1 VER-2
• Status: Unknown status
• Phase: N/A
• First received: December 4, 2008
• Last updated: December 4, 2008
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2008
• Source: Carmel Medical Center
• Contact: HADAR KESSARY, PhD
• Phone: 972-4-6277101
• Email: HADAR[@]CS-COMMONSENSE.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 224
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Infection

Intervention

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.

Locations

Country	Name	City	State
Israel	Lin Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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