Status:
COMPLETED
A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Maastricht University Medical Center
Center of Expertise for Chronic Organ Failure
Conditions:
Emphysema
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment ...
Detailed Description
Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment ...
Eligibility Criteria
Inclusion
- COPD.
- FEV1 ≤45%pred AND FEV1/FVC \<70%.
- TLC \>100%pred AND RV\>175%pred.
- CAT ≥18.
- \>50% emphysema destruction @-910HU.
- \>95% complete major fissure measured by quantitative CT analysis.
- Non-smoking \>6 months.
- Signed informed consent.
Exclusion
- PaCO2\>8.0 kPa, or PaO2\<6.0kPa.
- 6-minute walk test \<160m.
- Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
- 3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments
- Previous lobectomy, LVRS, or lung transplantation.
- LVEF\<45% and or RVSP\>50mmHg.
- Anticoagulant therapy which cannot be weaned off prior to procedure.
- Patient is significantly immunodeficient.
- Involved in other pulmonary drug studies within 30 days prior to this study.
- Pulmonary nodule which requires intervention
- Any disease or condition that interferes with completion of initial or follow-up assessments
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03474471
Start Date
July 31 2018
End Date
April 20 2023
Last Update
May 10 2023
Active Locations (2)
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1
University Medical Center Groningen
Groningen, Netherlands
2
CIRO
Horn, Netherlands