RecruitingNot ApplicableNCT04801108

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

20 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a procedure to complete an incomplete natural boundary (fissure) in the lung — during a valve placement procedure (Zephyr valve) — helps people with severe emphysema breathe better by achieving better lung volume reduction. **You may be eligible if...** - You are between 40 and 75 years old - You have emphysema (a type of serious lung disease) - You have not smoked for at least 4 months and agree to stay smoke-free during the study - You completed a pulmonary rehabilitation program within the past 12 months - You are on a stable, low dose of steroids (less than 10mg prednisone daily) **You may NOT be eligible if...** - You have had a recent serious lung infection or hospitalization - You have other serious health conditions affecting your lungs or heart - You are currently smoking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERobotic 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.

DEVICEEndobronchial valves placement

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


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT04801108


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