Status:
WITHDRAWN
Introduction of the Vapor Treatment in The Netherlands
Lead Sponsor:
University Medical Center Groningen
Conditions:
Emphysema or COPD
Eligibility:
All Genders
Brief 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 inclusio...
Detailed Description
Rationale: The STEP-UP trial investigated the bronchoscopic lung volume reduction treatment using vapor and showed that the treatment group significantly improved after 6 months compared to the contro...
Eligibility Criteria
Inclusion
- 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
- 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.
- Highly diseased lower lobes (tissue to air ratio of \<11%)
- Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure \>45 mm Hg via echocardiogram.
- Subject has severe gas exchange abnormalities as defined by: PaCO2 \>8.0 kPa and/or PaO2 \< 6.0 kPa (on room air).
- Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
- Subject is taking \>5 mg prednisone (or equivalent dose of a similar steroid) daily.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04029077
Start Date
December 1 2021
End Date
December 1 2026
Last Update
March 14 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.