CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 475 enrolled
Drug / intervention
BreathScreen PEdevice
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.

Search/NCT00368836
NCT00368836Phase 3Completed
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Expired CO2/O2 Analysis to Diagnose Pulmonary Embolism

Wake Forest University Health Sciences·interventional·Posted Aug 29, 2006·Updated Apr 21, 2022

In Brief

A Phase 3 clinical trial evaluating BreathScreen PE for Pulmonary Embolism. Completed, enrolled 475 participants across 1 site.

Detailed Summary

A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not always accurate for individuals who have recently undergone surgery or who have inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen (O2) output, in individuals at risk for developing PEs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), WFD Ventures Incorporated

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartJan 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.8 years ago

Interventions

BreathScreen PEdevice

One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level