NCT04892719 - 4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation has finally changed its Overall Status from Recruiting to Completed and given AF’s latest video snippet about clinical trials driving the commercialisation progress, one could assume an announcement is imminent.
A brief Summary of NCT04892719:
This is a pilot study to determine the utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of chronic lung allograft dysfunction (CLAD) after lung transplantation.
Enrollment went from an anticipated 15 to an 18 actual.
Exclusion Criteria was as follows:
1. Recipients of a single lung transplant
2. Recipients of a redo-lung transplant
3. Recipients of bone marrow or stem cell transplant
4. Recipients of a multi-organ transplant
5. Patients with hospital admissions(excluding admissions for planned treatment of the CLAD and/or rejection)within one month of screening.
6. Patients who are unable to lie flat on the fluoroscopy table
7. Pregnant women (by subject's verbal report). Lung transplant recipients are routinely counseled to avoid pregnancy due to the teratogenic effects of necessary immunosuppressant medications. Pregnancy after lung transplantation is therefore extremely rare. As this is a minimal risk study which does not involve an experimental therapy, invasive devices, or increased risk procedures, pregnancy testing is deemed unnecessary for this population for this study.
Sponsors and Collaborators
Duke University
4D Medical
Investigators
Principal Investigator: Azfar Ali, MD Duke University
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