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.

Study Overview

• Status: Completed
• Conditions: Vaginitis
• Intervention / Treatment: Device: vs-sense

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Israel
  • West Galil
    • Haifa, West Galil, Israel
      • Lin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Symptomatic and asymptomatic women, ages 18 and above.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no treament	Device: vs-sense; detection swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Collaborators: Common Sense; Lin Medical Center, Haifa

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 11, 2009
• Last Update Submitted That Met QC Criteria: August 10, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: vaginal infection, color appearance
• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis
• Other Study ID Numbers: F-7-25.2-1