VS-Sense Result Reading Clarity

Vaginitis Clinical Trial

Official title:

VS-Sense Result Reading Clarity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803127
• Other study ID #: F-7-25.2-1
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: August 10, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vaginitis

Intervention

Device:
• vs-sense
detection swab

Locations

Country	Name	City	State
Israel	Lin Medical center	Haifa	West Galil

Sponsors (3)

Lead Sponsor	Collaborator
Carmel Medical Center	Common Sense, Lin Medical Center, Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 minuts	Yes