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NCT02052544 · ClinicalTrials.gov registry record
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
A clinical trial, sponsored by dsm-firmenich Switzerland.
- Completed
- Registry status
- 123
- Enrollment target
NCT02052544: Completed study, sponsored by dsm-firmenich Switzerland.
NCT02052544 is a clinical trial that has completed, run by dsm-firmenich Switzerland. The registered enrollment target is 123 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052544 has completed, sponsored by dsm-firmenich Switzerland.
- COMPLETED
- Registry status
- 123 participants
- Enrollment target
Study Summary
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k) submission.
Primary Outcome
Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-05 |
What the finished NCT02052544 record still lists
NCT02052544 is an observational study that tracks outcomes without assigning an intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02052544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02052544 about?
NCT02052544 is a clinical study titled "Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device". To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k) submission.
What is the current status of trial NCT02052544?
This trial is currently completed. The enrollment target is 123 participants. The study started on 2012-04. Estimated completion is 2013-05.
Who is sponsoring clinical trial NCT02052544?
This trial is sponsored by dsm-firmenich Switzerland, which has 13 total clinical trials registered on ClinicalTrials.gov.
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