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Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device

NCT02052544 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2015-05-06

Study results available
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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.

Conditions

  • Thromboembolic Events

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Wolfgang Korte · Deputy Head Institute for Clinical Chemistry and Hematology

  • Manuela K. Krause, MD · Deutsche Klinik für Diagnostik GmbH

  • Rathbun Suman, MD · University of Oklahoma Health Sciences Center- Department of Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052544 on ClinicalTrials.gov