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Clinical Trial Summary

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.


Clinical Trial 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01952431
Study type Interventional
Source PulmOne Advanced Medical Devices, Ltd.
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Status Completed
Phase N/A
Start date April 2013
Completion date September 2013