Introduction of the Vapor Treatment in The Netherlands (NCT04029077) | Clinical Trial Compass
WithdrawnNot Applicable
Introduction of the Vapor Treatment in The Netherlands
Stopped: COVID-19 and other treatments available
0Started 2021-12-01
Plain-language summary
Rationale: The bronchoscopic lung volume reduction treatment using vapor was found to be effective and the treatment has an acceptable safety profile. The results of this trial has led to the inclusion of this treatment in the COPD GOLD guidelines in 2019. In the Netherlands the treatment has not been performed so far but the treatment device has been made available to the UMCG hospital to perform emphysema treatments. Some of the patients refered to the UMCG could benefit from the Vapor treatment and therefore with this treatment we will be able to treat patients who have no other treatment options left.
Objective: The overall aim of this study is to gain experience with the Thermal Vapor treatment by investigating the safety and efficacy of the treatment.
Primary Objective:
The primary objective is to investigate the change in Lung function (measured by Forced Expiratory Volume in 1 second (FEV1)) between baseline and 6 months after the Thermal Vapor treatment.
Study designThis study will be a prospective observational, single center study. All patients that undergo the bronchoscopic lung volume reduction treatment using thermal Vapor will be asked if their data can be captured in the database.
Study population: Patients with severe COPD who undergo the Thermal Vapor treatment.
Who can participate
SexALL
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Inclusion criteria
✓. Diagnosis of COPD
✓. FEV1%pred \<45% and FVC\<70%pred,
✓. Severe lung hyperinflation: RV\>175%pred and RV/TLC\>55%
✓. Patients will have heterogeneous emphysema, as evidenced by high-resolution CT demonstrating a heterogeneity Index \>1.2 in at least one segment to be treated.
✓. Nonsmoking for at least 6 months prior to entering the study
✓. Completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
✓. Read, understood and signed the Informed Consent form.
Exclusion criteria
✕. FEV1 \< 15% predicted
✕. Inability to walk \>140 meters in 6 minutes (6MWD) following optimized medical management
✕. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
What they're measuring
1
Lung function
Timeframe: Between baseline and 6 months follow up