Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous Emphysema

Current treatment of emphysema (COPD gold III-IV) generally is limited to
palliative measures that include supplemental oxygen, bronchodilators,
anti-inflammatory drugs and pulmonary rehabilitation or to lung
transplantation. A small subset of patients with emphysema might benefit by
lung volume reduction surgery, but this procedure is highly invasive and often
results in high morbidity and mortality. A minimally invasive treatment with
the potential to improve pulmonary function and reduce dyspnea in patients with
homogeneous emphysema would provide meaningful clinical benefit.

To evaluate the mechanism of action and effecacy of the Lung Volume Reduction
Coil to improve QOL pulmonary function for homogeneous emphysema subjects with
severe hyperinflation.

single-center single arm study

Nitinol Lung Volume Ruduction Coils will be placed in both lungs during two
bronchoscopic procedures, with an interval of 2 months, aiming to induce a
volume reduction and therefore aiming to improve the clinical status of
emphysema patients with severe hyperinflation by improving pulmonary mechanics.

The patients that will be screened for potential participation will recieve
pulmonary function testing, thoracic HRCT scanning (both are often already
available) and an outpatient visit. The patients that will be included will
have to come to our outpatient clinic, perform pulmonary function testing, a 6
min walking test, thoracic x-ray and testing of blood samples and arterial
bloodgas. For the actual treatment with bronchoscopy under general anesthesia
the patients will stay two times two days in our hospital. For the follow-up, 1
CT scan, 3 pulmonary function tests, three 6 min walking tests and 3 outpatient
clinic visits will be needed The included patients will have to put large
effort in the study, but is in balance with the expected outcome and very
limited compared 'alternative' treatments like highly invasive surgery: Lung
volume reduction surgery or Lung transplantation. All included patients have a
severe limitation of their activities of daily living. With the development and
validation of the use of the airway bypass procedure does it seem possible to
give -at least temporarily- relieve of shortness of breath and improvement in
expercise performance. Furthermore can this technique be used as a 'bridge' to
lungtransplantation in future, or will be the only possible therapeutic tool
available by then. The risks are not bigger than the risks any individual has
for the investigations described. The actual treatment with the LVR-Coils can
cause: airway bleeding, airway infections and fever, pneumothorax, cough (that
might result in an additional bronchoscopy to remove the coils), or death as a
result of one of these complications.