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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 is a clinical trial that has completed, run by dsm-firmenich Switzerland. The registered enrollment target is 123 participants.
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052544
The ClinicalTrials.gov registry entry for NCT02052544 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is dsm-firmenich Switzerland, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02052544 reports 0 study locations.
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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