VS-Sense Result Reading Clarity - Full Text View

Sponsors and Collaborators:	Carmel Medical Center Women Health Care Center - Lin Medical Center Common Sense
Information provided by:	Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT00803127

Purpose

This study is designed to demonstrate the result reading clarity of the VS-SENSE is substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for vaginal secretions.

Condition	Intervention
Vaginitis	Device: vs-sense

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	VS-Sense Result Reading Clarity

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

The clinician reports of the VS-SENSE test results, the pH measurement by Nitrazine Paper test records, and the results reading clarity grade from the clinician. [ Time Frame: 5 minuts ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

VAGINAL DISCHARGE

Estimated Enrollment:	120
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
no treament	Device: vs-sense detection swab

Detailed Description:

Once informed consent has been signed, the clinician will perform the following:

Record baseline variables in the CRF. The 1st clinician will obtain a vaginal secretion sample by using the VS-SENSE swab. The 1st clinician will obtain the specimen by separating the labia to expose the vagina. The yellow tip of the VS-SENSE swab will be inserted into the vagina approximately 5 cm/ 2". The 1st clinician will use the VS-SENSE according the instructions for use - attachment 1 to the protocol.

The 1st clinician will read the VS-SENSE results and record them on the designated form (Clinician Report - VS-SENSE Result form), and fill out the table regarding the VS-SENSE reading clarity on the same form.Vaginal examination (including speculum examination) - will be performed by a 2nd clinician, masked from the results of the 1st clinician test.

The 2nd clinician will use a vaginal swab for pH measurement by Nitrazine pH Paper test. The Nitrazine pH Paper test will be performed according to strict manufacturer's instruction.

The 2nd clinician will read the results of the Nitrazine pH Paper test result, document it on the Clinician Report - pH Test Result form, and fill out the table regarding the pH test reading clarity on the same form.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Symptomatic and asymptomatic women, ages 18 and above.

Criteria

Inclusion Criteria:

Symptomatic women, ages 18 and above.
Subjects willing and able to sign the informed consent form.

Exclusion Criteria:

Subjects are unable or unwilling to cooperate with study procedures.
Subjects are currently participating in other clinical study that may directly or indirectly affect the results of this study.
Women with blood present in their vaginal secretion.
Subjects that have had sexual relations or applied vaginal douched within the previous 12 hours.
Subjects that applied vaginal medications within the last 3 days.
Subjects with symptoms and signs of pelvic inflammatory disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803127

Contacts

Contact: hadar kessary, PhD

972-4-6277101 ext 126

HADAR@CS-COMMONSENSE.COM

Locations

Israel, West Galil
Lin Medical center
Haifa, West Galil, Israel

Sponsors and Collaborators

Carmel Medical Center

Women Health Care Center - Lin Medical Center

Common Sense

More Information

Responsible Party:	common sense ( hadar kessary )
Study ID Numbers:	F-7-25.2-1
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803127
Health Authority:	Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Carmel Medical Center:

vaginal infection, color appearance

Study placed in the following topic categories:

Genital Diseases, Female
Vaginitis
Vaginal Diseases

ClinicalTrials.gov processed this record on January 16, 2009