Clinician-Collected Versus Patient-Collected Cervical Pap Smears
Status: | Archived |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | February 2011 |
End Date: | December 2011 |
A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
The purpose of this study is to see if it is possible to conduct a full study to determine
whether the SoloPapâ„¢ cervical cell sample collection kit is as good as a clinician performed
Pap test in detecting precancerous cervical lesions in females.
Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a
convenient and private way to collect samples and ship them to a laboratory for processing.
The current study is pilot/pre-cursor study for a larger subsequent study that aims to
determine whether SoloPap is truly noninferior to clinician-collected Pap smears in
detecting cervical pathology. It will also determine user preference and willingness to
perform a self- test.
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