Status:
COMPLETED
VS-Sense Result Reading Clarity
Lead Sponsor:
Carmel Medical Center
Collaborating Sponsors:
Lin Medical Center, Haifa
Common Sense
Conditions:
Vaginitis
Eligibility:
FEMALE
18-70 years
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.
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 s...
Eligibility Criteria
Inclusion
- Symptomatic women, ages 18 and above.
- Subjects willing and able to sign the informed consent form.
Exclusion
- Subjects are unable or unwilling to cooperate with study procedures.
- Subjects are currently participating in other clinical study that may directly or indirectly affect the results of this study.
- Women with blood present in their vaginal secretion.
- Subjects that have had sexual relations or applied vaginal douched within the previous 12 hours.
- Subjects that applied vaginal medications within the last 3 days.
- Subjects with symptoms and signs of pelvic inflammatory disease.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00803127
Start Date
January 1 2009
End Date
May 1 2009
Last Update
August 11 2009
Active Locations (1)
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1
Lin Medical center
Haifa, West Galil, Israel