Performance Proof of the New NORMA-SENSE

• Sponsor: Carmel Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00802763
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Duration (Months): 5.9
• Patients Per Site Per Month: 37.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Infection	Device: NORMA-SENSE

Study Design

• Study Type: Observational
• Anticipated Enrollment: 224 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD
• Study Start Date: Feb 1, 2009
• Anticipated Primary Completion Date: Jul 1, 2009
• Anticipated Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lin Medical center	Haifa		Israel

Sponsors and Collaborators

• Carmel Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00802763
• Other Study ID Numbers: F-7-28.1-1 VER-2
• First Posted: Dec 5, 2008
• Last Update Posted: Dec 5, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: VAGINAL INFECTION; COLOR APPEARANCE; ELEVATED Ph
• Additional relevant MeSH terms: Infections

Study Results

No Results Posted as of Dec 5, 2008