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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Upper-lobe predominant emphysema |
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| 2 | Active Comparator | Non-upper lobe predominant emphysema |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-bronchial valve (Spiration IBV) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan | 6 months | |
| To estimate the difference between study arms in residual volume | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pallav Shah, MBBS, MD | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
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|
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| To estimate the difference between study arms in FEV1 |
| 6 months |
| To estimate the difference between study arms in gas transfer | 6 months |
| To estimate the difference between study arms in modified MRC dyspnoea score | 6 months |
| To estimate the difference between study arms on a 6 minute walk test | 6 months |
| To estimate the difference between study arms in disease specific health status | 6 months |
| To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry | 6 months |
| To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength | 6 months |