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Home > Lung Flute® > Therapeutic

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Therapeutic Use

Given the potential efficacy of the Lung Flute® with respect to mobilizing deep lung secretions based on diagnostic data, we are commencing a therapeutic clinical trial at the Buffalo N.Y. VA hospital in the Autumn of 2007. Depending on the results of this clinical trial, the Company hopes to submit a FDA 510(k) application for therapeutic use in 2008. If successful, this clinical trial  will support the use of the Lung Flute® as an effective modality for improved treatment of pulmonary congestion.

Subject Protocol

  • 40 COPD subjects divided into 2 groups:
    • Predicate device therapy group
    • Lung Flute® therapy group
  • Subjects will be assessed at regular intervals
  • 2 months in duration

Assessment Tools

  • At regular intervals the following will be assessed:
    • Pulmonary function test
    • Resting oximetry
    • Six minute walk
  • Subjects will complete a Visual Analogue Dyspnea Scale at regular intervals