Performance Proof of the New NORMA-SENSE

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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Infection
• Intervention / Treatment: Device: NORMA-SENSE

• Study Type: Observational
• Enrollment (Anticipated): 224

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Lin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women, age greater then 18 without symptoms of vaginal infection.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vaginitis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): December 5, 2008
• Last Update Submitted That Met QC Criteria: December 4, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: VAGINAL INFECTION; COLOR APPEARANCE; ELEVATED Ph
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: F-7-28.1-1 VER-2