Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309628
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
Sponsor:
Paragonix Technologies
Organization:
Paragonix Technologies
Study Overview
Official Title:
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will sample and analyze volatile organic compounds VOCs from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy
Detailed Description:
The aim of this study is to sample and analyze volatile organic compounds VOCs from participants considered to be at risk for developing rejection following lung transplant By using infrared spectroscopy the breath sample analysis will help investigators describe and identify patterns of VOCs that are over- or under-represented in patients with post-lung transplant rejection when compared to the breath profiles of those without rejection It is hypothesized that the profile of volatile chemicals in the breath of patients in the early stages of rejection will differ significantly from those individuals without rejection
Primary objective
To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematicalstatistical models of infrared absorption spectrum for identification of rejection
Secondary objective
To determine the best method to classify health status based on VOC data of breath samples
To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients
The study is an unblinded prospective case-control study The study cohorts will include 1 patients with confirmed post-lung transplant rejection via biopsy and 2 control patients who have undergone lung transplant but are free from rejection as confirmed via biopsy Breath samples collected from participants will be analyzed to characterize and further identify differences in infrared absorption profiles from each cohort using infrared spectroscopy The data will be used to validate a previously developed machine learning algorithm
Primary objective
To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematicalstatistical models of infrared absorption spectrum for identification of rejection
Secondary objective
To determine the best method to classify health status based on VOC data of breath samples
To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients
The study is an unblinded prospective case-control study The study cohorts will include 1 patients with confirmed post-lung transplant rejection via biopsy and 2 control patients who have undergone lung transplant but are free from rejection as confirmed via biopsy Breath samples collected from participants will be analyzed to characterize and further identify differences in infrared absorption profiles from each cohort using infrared spectroscopy The data will be used to validate a previously developed machine learning algorithm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None