Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2009-01-31
2009-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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no treament
vs-sense
detection swab
Interventions
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vs-sense
detection swab
Eligibility Criteria
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Inclusion Criteria
2. Subjects willing and able to sign the informed consent form.
Exclusion Criteria
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.
18 Years
70 Years
FEMALE
Yes
Sponsors
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Lin Medical Center, Haifa
OTHER
Common Sense
OTHER
Carmel Medical Center
OTHER
Responsible Party
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common sense
Locations
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Lin Medical center
Haifa, West Galil, Israel
Countries
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Other Identifiers
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F-7-25.2-1
Identifier Type: -
Identifier Source: org_study_id
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