Clinician-Collected Versus Patient-Collected Cervical Pap Smears (SoloPaP)
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|ClinicalTrials.gov Identifier: NCT01214330|
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : November 20, 2014
Last Update Posted : November 21, 2014
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ 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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Device: Patient-Collected Cervical Pap Smear||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Patient-Collected Cervical Pap Smear
women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear
Device: Patient-Collected Cervical Pap Smear
Patient-Collected Cervical Papanicolaou Smear
Other Name: SoloPap
- Concordance (Similarity Between Samples) of Pap Smears [ Time Frame: 1 year ]Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?
- Patient Attitudes [ Time Frame: 6 months ]Results from SoloPap Patient Questionairre regarding patient attitudes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214330
|United States, Nevada|
|Mike O'Callaghan Federal Hospital/Nellis Air Force Base|
|Las Vegas, Nevada, United States, 89191|
|Principal Investigator:||Paul Crawford, M.D.||Mke O'Callaghan Federal Hospital|