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Heartsbreath Test for Heart Transplant Rejection

NCT01397812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2015-04-07

No results posted yet for this study

Summary

The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).

Conditions

  • Heart Transplant Rejection

Interventions

DEVICE

BreathScanner 1.0

For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.

DEVICE

BreathLink

The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Menssana Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Phillips, MD, FACP · Menssana Research, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2016-09-30

Countries

  • United States

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 NCT01397812 on ClinicalTrials.gov