Status:
RECRUITING
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Emphysema or COPD
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental inte...
Detailed Description
The investigators will approach all patients with failed EBV therapy. Patients with less than 350 ml of volume reduction in the target lobe and persistent dyspnea \[score greater or equal to 2 on the ...
Eligibility Criteria
Inclusion
- Age 40 to 75 years.
- Stable with less than 10mg prednisone (or equivalent) daily.
- Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
- Current pneumococcus vaccination.
- Current influenza vaccination.
- Target lung volume reduction \<350ml after bronchoscopic lung volume reduction (BLVR).
- Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR).
- Endobronchial valves (EBV) are still in place.
- Willing and able to complete protocol required study follow-up assessments and procedures.
Exclusion
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Decompensated heart failure.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Prior lung transplant, LVRS, bullectomy, or lobectomy.
- Clinically significant bronchiectasis.
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Resting bradycardia (\<50 bpm), Complex ventricular arrhythmia, sustained SVT.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05257681
Start Date
May 24 2022
End Date
May 24 2026
Last Update
April 6 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215