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| Name | Class |
|---|---|
| Deep Breeze | INDUSTRY |
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This study is a prospective, multi-center study. 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months These patients will undergo a baseline VRI recording prior to the interventional procedure and a follow-up VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as well as before and 1 hour after any recurrent interventional procedure
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:
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:
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| Measure | Description | Time Frame |
|---|---|---|
| The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray]. | 6 months |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be entered into the study:
Exclusion Criteria:
Any of the following will exclude the subject from study:
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50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Welte, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | 30625 | Germany |
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| ID | Term |
|---|---|
| D007239 | Infections |
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