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General |
Study Status |
Other |
Application Number / Requirement Number |
P040052 / PAS001 |
Date Original Protocol Accepted |
12/18/2007
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Date Current Protocol Accepted |
12/18/2007
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Study Name |
CHOICE Study
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Device Name |
MONOPREP PAP TEST
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General Study Protocol Parameters |
Study Design |
Cross-Sectional Study
|
Data Source |
New Data Collection
|
Comparison Group |
Historical Control
|
Analysis Type |
Descriptive
|
Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
The study consists of consecutive patients for whom a MonoGen Pap Test is performed at the participating laboratories constitute the MonoGen Pap Test arm of this study. These patiens will be compared to historical Pap smear slides from the same laboratories.
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Study Population |
Study Population: Patients 18 years or older, with a Pap test and a minimum of 400 HSIL. There were also 360 patients who have an accompanying colposcopy/biopsy results. Indication: The MPPT is intended for use in collecting and preparing cervical-vaginal cytology specimens for Pap stain-based screening for cervical cancer, its precursor lesions, and other cytologic categories and conditions defined by the 2001 Bethesda System for Reporting Results of Cervical Cytology.
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Sample Size |
400 HSIL patients and 360 patients with an accompanying colposcopy/biopsy, 3 sites
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Key Study Endpoints |
Data will be collected on the MonoGen Pap test results for MPPT patients and Pap smear results will be obtained from the control patients. The endpoint includes cervical cytology results from cervical-vaginal cytology specimens using both MPPT method for the prospective arm and PS method for the historical arm. For cases with cytologic diagnosis of HSIL+ from both MPPT and PS arms, comparative data from histological examination (colposcopy and, if appropriate, biopsy) will be collected.
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Follow-up Visits and Length of Follow-up |
Follow-up was not required for this study.
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Interim or Final Data Summary |
Interim Results |
The study was terminated early because the sponsor does not intend to market the device.
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