Ignite Creation Date:
2025-12-18 @ 10:09 AM
Ignite Modification Date:
2025-12-23 @ 11:29 PM
Study NCT ID:
NCT00744822
Status:
None
Last Update Posted:
2008-09-01 00:00:00
First Post:
2008-08-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vibration Response Imaging (VRI) in Lung Transplant Recipients
Sponsor:
None
Organization:
Study Overview
Official Title:
Vibration Response Imaging (VRI) in Lung Transplant Recipients
Status:
None
Status Verified Date:
2005-12
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:
* Study participants will be patients who have undergone lung transplantation during the last 6 months and are in a stable clinical position at the time of enrollment.
* Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
* The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:
* Baseline after study enrollment (VRI Recording 1 + standard evaluations).
* At each follow-up visit \[1, 3, 6 months after baseline visit\] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
* In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
* 1 hour after all bronchoscopic interventional procedures.
* In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
* All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take \~15 minutes \[the actual recording is \~2 minutes for placement and breathing/recording\].
* Standard evaluation procedures may include any of the following:
* Lung function tests (this test is required at all visits)
* Physical examination
* Bronchoscopy (e.g. transbronchial biopsy)
* CT-imaging
* Chest x-ray
* V/Q Scan (Baseline visit for single lung transplantation)
* Blood gases (this test is required at all visits)
* Blood tests
* Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
* The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:
* Baseline after study enrollment (VRI Recording 1 + standard evaluations).
* At each follow-up visit \[1, 3, 6 months after baseline visit\] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
* In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
* 1 hour after all bronchoscopic interventional procedures.
* In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
* All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take \~15 minutes \[the actual recording is \~2 minutes for placement and breathing/recording\].
* Standard evaluation procedures may include any of the following:
* Lung function tests (this test is required at all visits)
* Physical examination
* Bronchoscopy (e.g. transbronchial biopsy)
* CT-imaging
* Chest x-ray
* V/Q Scan (Baseline visit for single lung transplantation)
* Blood gases (this test is required at all visits)
* Blood tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: