Back to search results

Combined Zephyr Valve System with Fissure Completion for Emphysema

This study is looking at a new way to treat severe emphysema or chronic obstructive pulmonary disease (COPD) in people aged 40 to 75. It combines two procedures: the Zephyr Valve System (endobronchial valves) and a procedure called lobar fissure completion. The lobar fissure completion uses surgery (either robotic or video-assisted thoracic surgery, VATS) to seal off parts of the lung. The goal is to see if adding fissure completion to the Zephyr Valve System helps more than just standard medical care. Researchers want to prove that fissure completion can be done successfully and that patients who agree to the procedure will actually receive it. They also want to track any serious side effects. This study aims to enroll 20 participants, but its current status is unclear.

Study design
This is a pilot prospective randomized controlled clinical trial. Participants will be randomly assigned to either receive the combined procedure or medical management.
What's involved
You would undergo screening, complete questionnaires, and potentially have a surgical procedure under general anesthesia, followed by endobronchial valve placement.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for an average of 2 years to track outcomes and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04801108

Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema

Recruiting
NAAges 40–75InterventionalTreatment
Beth Israel Deaconess Medical Center
~20 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Robotic or VATS lobar fissure completionEndobronchial valves placement

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% via robotic thoracic surgery or VATS in severe emphysema patients
Measured over 2 years
+2 more outcomes 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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.
Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
Current pneumococcus vaccination.
Current influenza vaccination.
Willing and able to complete protocol required study follow-up assessments and procedures.

Exclusion

\> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
Clinically significant (greater than 4 tablespoons per day) mucus production.
Myocardial infarction within 6 months of screening.
Uncontrolled congestive 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 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.
TLC less than 100% predicted (determined by body plethysmography at screening).
RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).
DLCO less than 20% of the predicted value at screening.
Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening.
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% via robotic thoracic surgery or VATS in severe emphysema patients2 years

    We will determine that we met this feasibility objective if the target inter-lobar fissure can be completed in at least 90% of the patients undergoing surgery.

  • Prove that patients consented for the procedure will ultimately undergo the intervention2 years

    We will determine that the study is feasible if at least 90% of consented patients in the intervention arm undergo the procedure.

  • Incidence of severe adverse eventsThrough study completion, an average of 2 years

    We will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the combined 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.