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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.
Full description
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).
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Inclusion criteria
Subject is at least 18 years of age.
Subject is cooperative and capable of following instructions.
Healthy subjects:
Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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100 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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