Actively Recruiting
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
P
Pulmonx Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.
CONDITIONS
Official Title
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Greater than 95% fissure completion on high-resolution chest CT-scan or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
- Clinically significant mucus production (greater than 4 tablespoons per day).
- 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, lung volume reduction surgery, 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 Cor Pulmonale.
- Left ventricular ejection fraction less than 40%.
- Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained supraventricular tachycardia.
- Post-bronchodilator FEV1 less than 15% or greater than 45% of predicted.
- Total lung capacity less than 100% predicted.
- Residual volume less than 150% predicted in heterogeneous emphysema or less than 200% predicted in homogeneous emphysema.
- Diffusing capacity of lung for carbon monoxide less than 20% predicted.
- Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters.
- Arterial carbon dioxide (PaCO2) greater than 50mmHg on room air.
- Arterial oxygen (PaO2) less than 45mmHg on room air.
AI-Screening
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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
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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