NCT04801108Recruiting
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Mar 2021
- Start date
- 1 Aug 2021
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- COPD
- NCT number
- NCT04801108
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Aug 2021 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Myocardial infarction within 6 months of screening.
- Uncontrolled congestive heart failure.
- Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
Lab values
- 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).
Other
- \> 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.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Clinically significant bronchiectasis.
- 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
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.