Vaginitis Clinical Trial
Official title:
VS-Sense Result Reading Clarity
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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