VS-Sense Result Reading Clarity

Israel Healthcare Foundation

Status: Completed

Conditions: Vaginitis

Treatments: Device: vs-sense

Study type: Observational

Funder types: Other

Identifiers

NCT00803127

F-7-25.2-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

120 participants in 1 patient group

no treament

Treatment:

Device: vs-sense