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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040052 / PAS002 |
| Date Original Protocol Accepted |
10/18/2007
|
| Date Current Protocol Accepted |
10/18/2007
|
| Study Name |
SURE Study
|
| Device Name |
MONOPREP PAP TEST
|
| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study was designed to have the 295 pairs (590 individual slides) of slides. Each subject was represented by a pair of slides: a Pap Smear slide and a MonoPrep Pap test slide. The MonoPrep Pap test slide was prepared from the Pap Smear slide residuum. Both sets of slides were assessed for specimen adequacy by the participating laboratories, and the slides were labeled as 'satisfactory' or 'unsatisfactory' accordingly. The adequacy determination (satisfactory/unsatisfactory status) and the underlying reason for an unsatisfactory status according to the TBS2001 criteria. For slides with adequacy determination of satisfactory, a diagnosis was assigned to the slide according to the TBS2001 criteria.
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| Study Population |
Study Poluation: Women 18 years or older who receive cervical cancer screening. Indication: The MonoGen Pap Test 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 |
295 patients, 85 sites
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| Key Study Endpoints |
The goal of the study was to evaluate cytology slides for adequacy determination and the underlying reason for unsatisfactory status. Data collection consisted of obtaining cervical cytology specimens.
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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 |
Study completed, see final results.
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| Actual Number of Patients Enrolled |
295
|
| Actual Number of Sites Enrolled |
N/A
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| Patient Follow-up Rate |
Follow-up was not required for this study.
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| Final Safety Findings |
The performance of MonoGen Pap Test and Pap Smear methods with regard to "miscall of unsatisfactory slides" are the same.
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| Study Strengths & Weaknesses |
A weakness of the study was that each slide evaluated by only one pathologist and not a panel of pathologists.
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| Recommendations for Labeling Changes |
The sponsor submitted a labeling change. The revisions submitted by the sponsor were not approved.
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