NCT01397812

Heartsbreath Test for Heart Transplant Rejection

Validation of Heartsbreath Test for Heart Transplant Rejection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Menssana Research, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.

Conditions

• Heart Transplant Rejection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2016-09-01
• First posted: 2011-07-20
• Last updated: 2015-04-07

Locations

5 sites across 1 country: United States