Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
ID04801108

Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial

Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-13

20

Participants Needed

1

Research Sites

N/A

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

Researchers are conducting a pilot randomized controlled trial to study a new lung fissure completion strategy combined with endobronchial valve (EBV) placement in patients with severe COPD or emphysema who have incomplete lung fissures (less than 95% completion). The goal is to see if completing the lung fissures surgically can reduce collateral ventilation between lung lobes and improve outcomes after EBV placement. The study will enroll about 20 patients and focus on complications, lung function tests, and symptom questionnaires over a 3-month follow-up. Participants will be randomly assigned to either receive the experimental intervention, which includes robotic or video-assisted thoracic surgery (VATS) to complete the lung fissure followed by EBV placement, or to a medical management group receiving usual care. The surgical procedure involves stapling the incomplete fissures under general anesthesia, followed by assessment of collateral ventilation and valve placement during the same or a closely timed procedure. Patients in the medical management group may choose to cross over to the intervention after 3 months. During the study, participants will undergo bronchoscopy, pulmonary function tests, quality of life questionnaires (Saint George Respiratory Questionnaire, COPD Assessment Test), and dyspnea assessment (modified Medical Research Council scale). Follow-up visits at 14 days and 3 months will collect clinical data, CT scans, and lung function results. Safety and adverse events will be monitored throughout, with a total participation period of about 3 months plus possible crossover treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 to 75 years
  • Stable on less than 10mg prednisone (or equivalent) daily
  • Nonsmoking for at least 4 months and willing to remain nonsmoking during the study
  • Completed supervised pulmonary rehabilitation within 12 months or regularly performing maintenance respiratory rehabilitation
  • Current pneumococcus vaccination
  • Current influenza vaccination
  • Willing and able to complete all required study follow-up assessments and procedures
Not Eligible

You will not qualify if you...

  • Greater than 95% fissure completion on CT scan or negative collateral ventilation by Chartis evaluation
  • Clinically significant mucus production greater than 4 tablespoons per day
  • Myocardial infarction within 6 months before screening
  • Uncontrolled congestive heart failure
  • Three or more pneumonia episodes in the past year
  • Three or more COPD exacerbations in the past year
  • Prior lung transplant, lung volume reduction surgery, bullectomy, or lobectomy
  • Clinically significant bronchiectasis
  • Unable to safely stop anticoagulants or platelet inhibitors for 7 days
  • Uncontrolled pulmonary hypertension or history of CorPulmonale
  • Left ventricular ejection fraction less than 40%
  • Resting bradycardia less than 50 beats per minute, frequent multifocal PVCs, complex ventricular arrhythmia, or sustained SVT
  • Post-bronchodilator FEV1 less than 15% or greater than 45% 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
  • DLCO less than 20% predicted
  • Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters
  • PaCO2 greater than 50 mmHg on room air
  • PaO2 less than 45 mmHg on room air

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Robotic or VATS Inter-Lobar Fissure Completion and EBVs Placement Procedure

Duration - Procedure day with possible deferral of valve placement within 48 hours

Participants undergo surgery to complete the lobar fissure using robotic or video-assisted thoracic surgery followed by placement of endobronchial valves during the same or closely timed procedure under general anesthesia.

1 procedure visit (in-person)

Follow-up After Intervention

Duration - 3 months

Participants are followed up with standard care visits after endobronchial valve placement including assessments of lung function, quality of life questionnaires, dyspnea scales, CT scans, and other clinical evaluations.

Visits at 14 days and 3 months post-procedure (in-person)

Medical Management Period

Duration - 3 months

Participants in the medical management group receive maximal medical therapy and are monitored with pulmonary function testing and quality of life assessments before offering crossover to the surgical intervention.

Routine medical visits during therapy period

Crossover Intervention and Follow-up

Duration - Procedure day plus 3 months follow-up

Participants initially assigned to medical management who choose to crossover undergo the same surgical procedure and follow-up schedule as the intervention group.

1 procedure visit and follow-up visits at 14 days and 3 months (in-person)

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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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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Published Research Related To This Trial

Employment and activity limitations among adults with chronic obstructive pulmonary disease--United States, 2013.

Anne G Wheaton, Timothy J Cunningham, Earl S Ford...

https://pubmed.ncbi.nlm.nih.gov/25811677

"Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary." Claus F. Vogelmeier, Gerard J. Criner, Fernando J. Martinez, Antonio Anzueto, Peter J. Barnes, Jean Bourbeau, Bartolome R. Celli, Rongchang Chen, Marc Decramer, Leonardo M. Fabbri, Peter Frith, David M.G. Halpin, M. Victorina López Varela, Masaharu Nishimura, Nicolas Roche, Roberto Rodriguez-Roisin, Don D. Sin, Dave Singh, Robert Stockley, Jørgen Vestbo, Jadwiga A. Wedzicha and Alvar Agusti. Eur Respir J 2017; 49: 1700214.

https://pubmed.ncbi.nlm.nih.gov/28642306

Combined Thoracoscopic Surgical Stapling and Endobronchial Valve Placement For Lung Volume Reduction With Incomplete Lobar Fissures: An Experimental Pilot Animal Study.

Adnan Majid, Fayez Kheir, Daniel Alape...

https://pubmed.ncbi.nlm.nih.gov/31436607

Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.

GBD 2015 Chronic Respiratory Disease Collaborators

https://pubmed.ncbi.nlm.nih.gov/28822787