Surgical Fissure Completion Tested in Emphysema After Failed Valve Treatment
Tests a surgical lung procedure in adults with emphysema or COPD after failed valve treatment.
Plain-language title generated from the registry record
Registry title: Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Key facts
- Where
- Boston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT05257681, who can take part
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beth Israel Deaconess Medical Center
- Trial code
- NCT05257681
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction
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.
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: Prior lung transplant, LVRS, bullectomy, or lobectomy; 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); Myocardial infarction within 6 months of screening; Decompensated heart failure; Resting bradycardia (<50 bpm), Complex ventricular arrhythmia, sustained SVT; Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days; Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit); Clinically significant (greater than 4 tablespoons per day) mucus production; Three or more pneumonia episodes in last year; Three or more COPD exacerbation episodes in the last year; Clinically significant bronchiectasis; PaCO2 greater than 50mmHg on room air at screening; PaO2 less than 45mmHg on room air at screening.