At a glance
ClinicalIndex Comparison RecordN/ACompleted· 123 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
In Brief
An observational study for Thromboembolic Events. Completed, enrolled 123 participants across 3 sites in 3 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolic Events
CountriesGermany, Switzerland, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
Primary CompletionMay 2013
First PostedFeb 2014
TodayJul 2026
First PostedFeb 3, 2014
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago