VS-Sense Result Reading Clarity

• Sponsor: Carmel Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00803127
• Collaborator: Lin Medical Center, Haifa (Other), Common Sense (Other)
• Enrollment: 120
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 30.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaginitis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: VS-Sense Result Reading Clarity
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lin Medical center	Haifa	West Galil	Israel

Sponsors and Collaborators

• Carmel Medical Center
• Lin Medical Center, Haifa
• Common Sense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00803127
• Other Study ID Numbers: F-7-25.2-1
• First Posted: Dec 5, 2008
• Last Update Posted: Aug 11, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: vaginal infection, color appearance
• Additional relevant MeSH terms: Vaginitis

Study Results

No Results Posted as of Aug 11, 2009