No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for patients with severe emphysema or COPD who did not improve after a certain lung treatment. If you join, you may undergo a surgical procedure to help improve your lung function.
Are You a Good Fit for This Trial?
Rules you outBronchiectasisUncontrolled pulmonary hypertensionHeart failureLow left ventricular ejection fractionBradycardiaVentricular arrhythmia
You may be able to join if
I am between 40 to 75 years old.
I have stable health and take less than 10mg of prednisone daily.
I have not smoked for the past 4 months and will not smoke during the study.
I have received the pneumococcus and influenza vaccinations.
I had less than 350ml of lung volume reduction after my bronchoscopic treatment.
I still have trouble breathing after that treatment.
My endobronchial valves are still in place.
I can complete all required follow-up assessments.
You may not be able to join if
I produce more than 4 tablespoons of mucus daily.
I had a heart attack in the past 6 months.
I have heart failure that is not controlled.
I have had three or more episodes of pneumonia in the past year.
I have had three or more episodes of COPD worsening in the last year.
I have had prior lung surgery.
I cannot stop anticoagulants or platelet inhibitors for 7 days safely.
I have uncontrolled pulmonary hypertension or related heart issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 w…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 reducti…
Inclusion Criteria:
* 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 Criteria:
* 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.
Contacts
No contact information available.
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