VS-Sense Result Reading Clarity

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Vaginitis

Clinical Trial Details

NCT number	NCT00803127
Study type	Observational
Source	Carmel Medical Center
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	May 2009

View Details

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