Introduction in the NEtherlands of the Vapor treatment for patients with severe Emphysema: a new Lungvolume reduction treatment
Withdrawn
- Conditions
- COPD10038716emphysema
- Registration Number
- NL-OMON49289
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patient is scheduled for a bronchoscopic lung volume reduction treatment
using Thermal Vapor
2. Read, understood and signed the Informed Consent form.
Exclusion Criteria
There are no exclusion criteria for this study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to investigate the change in Lung function which will<br /><br>be measured by Forced Expiratory Volume in 1 second (FEV1) between baseline and<br /><br>6 months after the Thermal Vapor treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety will be assessed by:<br /><br>The number and type of treatment- related adverse events during 1 years follow<br /><br>up after complete treatment.<br /><br><br /><br>Efficacy & long term follow up will be assessed by:<br /><br>The change in Lung function, lung hyperinflation, quality of life, dyspnea, CT<br /><br>parameters and exercise capacity between baseline and 6 and 12 months follow up<br /><br>after treatment. Longterm efficacy will be investigated up to 5 year follow up<br /><br>after treatment.<br /><br>Lung function: Spirometry and Bodyplethysmography<br /><br>Quality of Life: St. George*s Respiratory Questionnaire (SGRQ) and COPD<br /><br>Assessment test (CAT) questionnaire<br /><br>Dyspnea : modified Medical Research Council Scale<br /><br>CT parameters: Quantitative CT analyses<br /><br>Exercise capacity: 6-minute walk distance test (year 1-3-5)</p><br>