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Performance Proof of the New NORMA-SENSE

NCT ID: NCT00802763

Last Updated: 2008-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaginal Infection

Keywords

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VAGINAL INFECTION COLOR APPEARANCE ELEVATED Ph

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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vaginitis

NORMA-SENSE

Intervention Type DEVICE

Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.

Interventions

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NORMA-SENSE

Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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COMMON SENSE

Locations

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Lin Medical center

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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HADAR KESSARY, PhD

Role: CONTACT

Phone: 972-4-6277101

Email: [email protected]

Facility Contacts

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hadar kessary, PhD

Role: primary

Other Identifiers

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F-7-28.1-1 VER-2

Identifier Type: -

Identifier Source: org_study_id