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Inter-lobar Fissure Completion for Failed Bronchoscopic Lung Volume Reduction

This study is looking at a surgical procedure called inter-lobar fissure completion and pleural adhesiolysis for people with severe emphysema or COPD. These are lung conditions that make it hard to breathe. This procedure is for patients who have already had a treatment called bronchoscopic lung volume reduction (BLVR) using endobronchial valves (EBVs), but it didn't work well enough. The surgery uses a stapler to complete the lung fissures (the natural divisions in your lungs) and remove any sticky tissues (adhesions). Researchers want to see if this surgery can improve outcomes for these patients. They plan to enroll 20 participants between 40 and 75 years old who meet specific health criteria, including not smoking. The main goals are to see if the fissures can be completed to at least 95% and to track any serious side effects over two years.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
You would undergo a surgical procedure (video-assisted thoracic surgery or robotic approach). Information from your medical records, including appointments, walking tests (6MWD), and lung function tests (PFTs), will be collected. You will also complete questionnaires about your quality of life and breathing difficulties.
Compensation
Not stated in the trial record.
Follow-up
The study will track the completion of lung fissures and any severe side effects for two years after the procedure.

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NCT05257681

Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction

Recruiting
NAAges 40–75InterventionalTreatment
Beth Israel Deaconess Medical Center
~20 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Interlobar fissure completion and pleural adhesiolysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction
Measured over 2 years
+1 more outcome measured

Conditions

Emphysema or COPD

Explore related trials

Chronic Obstructive Pulmonary DiseaseEmphysema

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Adnan Majid, MD FCCP
[email protected]
617 6328252
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction2 years

    The investigators will determine that performing the surgery is feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled.

  • Incidence of severe adverse events2 years

    The investigators will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.