Actively Recruiting
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.
CONDITIONS
Official Title
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 75 years
- Stable on less than 10 mg prednisone (or equivalent) daily
- Non-smoker for at least 4 months before screening and willing to remain non-smoking during the study
- Current pneumococcus vaccination
- Current influenza vaccination
- Target lung volume reduction less than 350 ml after bronchoscopic lung volume reduction
- Persistent breathlessness with mMRC score of 2 or higher after bronchoscopic lung volume reduction
- Endobronchial valves still in place
- Willing and able to complete all required study assessments and procedures
You will not qualify if you...
- Producing clinically significant mucus (more than 4 tablespoons per day)
- Heart attack within 6 months before screening
- Decompensated heart failure
- Three or more pneumonia episodes in the last year
- Three or more COPD exacerbations in the last year
- Previous lung transplant, lung volume reduction surgery, bullectomy, or lobectomy
- Clinically significant bronchiectasis
- Unable to safely stop anticoagulants or platelet inhibitors for 7 days
- Uncontrolled pulmonary hypertension (systolic pressure over 45 mmHg) or history of Cor Pulmonale
- Left ventricular ejection fraction less than 40%
- Resting slow heart rate (below 50 bpm), complex arrhythmias, or sustained supraventricular tachycardia
- Carbon dioxide level (PaCO2) greater than 50 mmHg on room air at screening
- Oxygen level (PaO2) less than 45 mmHg on room air at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here