TLC in Patients With and Without Respiratory System Disease Clinical Trial
Official title:
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized comparative study.
This study is a prospective, multi-centered, randomized, comparative study designed to demonstrate substantially equivalence performance of the proposed device, the PulmOne MiniBoxPFT, to its predicate device, the ZAN500, for the measurement of total lung capacity (TLC). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic