Recruiting

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

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04801108

Conditions

Emphysema or COPD

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Robotic or VATS lobar fissure completion

Endobronchial valves placement

Study Details

Brief summary:

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

Emphysema or COPD

Study ID

NCT04801108

Start date

Aug 1, 2021

Status verified date

Apr, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.
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 Criteria:

> 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Medical management group

COPD patients with severe emphysema and incomplete lobar fissures will be placed on maximal medical therapy for 3 months. At the end of this 3 month period, patients will fill in an additional set of quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. New pulmonary function testing will be performed and crossover to the intervention group will be offered.

experimental: Intervention group

COPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.

experimental: Crossover group

Subjects allocated to the medical management group will be offered to crossover after the 3 months follow-up period. The same procedure as in the intervention group will be performed. Follow-up after surgery will be the same as in the intervention group.

Interventions

Robotic or VATS lobar fissure completion

The lobar fissure adjacent to the target lobe will be completed using a surgical stapler through robotic or video-assisted thoracic surgery.

Endobronchial valves placement

Endobronchial valves will be placed in the target lobe after the fissure completion.

Primary outcome measure

Prove that inter-lobar fissures can be completed to at least 95% via robotic thoracic surgery or VATS in severe emphysema patients [ Time Frame: 2 years ]
Prove that patients consented for the procedure will ultimately undergo the intervention [ Time Frame: 2 years ]
Incidence of severe adverse events [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Adnan Majid, MD FCCP

617 6328252 amajid@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD FCCP

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

COPD
Endobronchial valves
Emphysema
Video-assisted thoracic surgery
Robotic thoracic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-13.