Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
Royal Brompton Hospital
London, United Kingdom
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Time frame: 6 months
To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
Time frame: 6 months
To estimate the difference between study arms in residual volume
Time frame: 6 months
To estimate the difference between study arms in FEV1
Time frame: 6 months
To estimate the difference between study arms in gas transfer
Time frame: 6 months
To estimate the difference between study arms in modified MRC dyspnoea score
Time frame: 6 months
To estimate the difference between study arms on a 6 minute walk test
Time frame: 6 months
To estimate the difference between study arms in disease specific health status
Time frame: 6 months
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
Time frame: 6 months
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.