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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P950039 S026/ PAS001 |
| Study Name |
ThinPrep 5000-Post-Approval Study
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| Device Name |
THINPREP-5000
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
External Registry
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| Comparison Group |
Concurrent & Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of this study is to evaluate the performance of the TP-5000 processors in detection of ASC-H+ and HSIL+ disease in a clinical use setting compared to the detection of ASC-H+ and HSIL+ disease in the same clinical setting using the TP-2000 processors. This evaluation will be performed at multiple sites.
A secondary objective is to compare the prospective and retrospective percent biopsy confirmed rate for all ASC-H+ and HSIL+ diagnosis. This evaluation will be performed at least one site.
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| Study Population |
The study population is the entire routine screening population of the selected sites.
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| Sample Size |
Sample size will be determined by the selection of clinical laboratories included in the study and duration of the study.
There will be at least five (5) clinical laboratories participating in this study.
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| Key Study Endpoints |
Data from all cytologic results for all patients screened during the study specific time period, which will be converted into prevalence rates for study reporting.
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| Follow-up Visits and Length of Follow-up |
24 months
Disease prevalence rates will be collected and reported on a quarterly basis.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Not applicable. This is a prevalence rate study and there are no study subjects.
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| Actual Number of Sites Enrolled |
Five (5)
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| Patient Follow-up Rate |
Not applicable. This is a prevalence rate study and there are no study subjects.
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| Final Safety Findings |
The Post-Approval Study confirms the safety of the ThinPrep 5000 Processor for the same clinical use as the ThinPrep 2000 Processor.
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| Final Effect Findings |
The Post-Approval Study confirms the effectiveness of the ThinPrep 5000 Processor for the same clinical use as the ThinPrep 2000 processor.
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| Study Strengths & Weaknesses |
Study Strength: The study is a Multi-Center study of prospective data of cytological specimens prepared with the ThinPrep 5000 Processor and retrospective data of cytologic specimens prepared with the ThinPrep 2000 Processor. No clinical or laboratory workflow was impacted by the study.
Study Weakness: The study duration (31 ½ months from site selection to final report) is the only weakness identified.
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| Recommendations for Labeling Changes |
No labeling changes are recommended.
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