A Non-randomized Study to Evaluate the Safety and Performance of the Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung

Currently, there is no non-invasive procedure that can adequately alleviate the
debilitating effects of severe emphysema. Self-care, medications, long-term
oxygen therapy, and surgery are either insufficient or too invasive (e.g., lung
transplant) for the compromised patient.
To fulfill the unmet needs, Portaero, Inc. has developed the Portaero
Pneumostoma System consisting of the surgical Portaero Access Tube device and
its accessory components to create a channel from the interior of the lung
through the thoracic wall and exposing it to atmosphere, and the Portaero
Disposable Tubes to maintain the channel after it has properly healed and
formed. The goal is to expel trapped gas in the emphysematous lung. The
potential benefits of the Portaero Pneumostoma System include an increase in
exhaled airflow and gas exchange, and decrease in work of breathing, residual
volume, and dyspnea with subsequent improvement in patient*s quality of life.

New information gathered from previous pilot work lead efforts to redesign the
Portaero Access Tube and Portaero Disposable Tube. To bring the next generation
Portaero devices to the Investigators, this protocol is developed to evaluate
the redesigned Portaero Pneumostoma System. The new designs are anticipated to
improve comfort and minimize device displacement observations.

The objective of this study is to evaluate the safety and device performance of
the Portaero Pneumostoma System to create and maintain a transthoracic
pneumostoma in patients with severe emphysema and hyperinflation.

This is a prospective, non-randomized, multicenter study to evaluate the safety
and device performance of the Portaero System for use in a unilateral
transthoracic pneumostoma procedure.

Pneumostoma Surgical Technique
The Portaero Access Tube is placed either percutaneously or through a small
incision, 4-8 cm in length, on the chest wall of the target lung. In both
insertion techniques, a chest drain is placed in the thoracic pleural space to
assist re-inflation of the lung. The use of vacuum or underwater seal to manage
the chest drain will be at the discretion of the surgeon.
A portion of the underlying rib at the access point can be resected to provide
operating space if required.
A second portal of entry may also be created for endoscopic visualization of
the pleural cavity and insertion of an intercostal catheter for post operative
drainage of air from the pleural cavity.

SCREENING: Outpatient Clinic Visit, Blood, Lung function tests, chest X-ray,
HRCT scan of the lungs, Echo of the heart
Included subjects will undergo a pulmonary rehabilitation program for
approximately 6 weeks and then:

BASELINE: Outpatient clinic visit, lung function tests, 6-minute walk test, 2 x
bicycle test

RECORDING: the patient will be admitted to the hospital for 1-2 week for the
surgery under general anesthesia.

FOLLOW-UP: five Outpatient clinic visits, two pulmonary function test, two
times 6 minutes walk test, 4 chest X-ray, an HRCT-scan of the lungs, two
bicycle tests

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 Pneumostomoa 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 following list of potential risks associated with the transthoracic
pneumostoma procedure are summarized below:
* Acute respiratory failure
* Infection (i.e., local pneumostoma infection)
* Anesthetic reaction
* Inflammation
* Bleed (i.e., hemorrhage, hemoptysis, local pneumostoma bleed)
* Pneumomediastinum
* Pneumothorax
* Bronchocutaneous fistula
* Respiratory infection
* COPD exacerbation
* Subcutaneous emphysema
* (Worsening of) Dyspnea
* Transient pain/discomfort at pneumostoma site
* Granulation tissue
* Death