RecruitingNot ApplicableNCT05257681

Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction

Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

20 participants

Start Date

May 24, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical procedure to help people with severe emphysema who did not benefit enough from a previous lung treatment called bronchoscopic lung volume reduction (BLVR). The surgery completes an incomplete fissure (a natural dividing line) in the lung to help the one-way valves already placed work better and reduce lung overinflation. **You may be eligible if...** - You are between 40 and 75 years old - You still have the endobronchial valves (placed during your previous BLVR procedure) in place - You are still very short of breath after your BLVR procedure - Your previous BLVR reduced lung volume by less than 350 ml - You have not smoked for at least 4 months and are willing to stay smoke-free during the study - You are up to date on your pneumococcal and influenza vaccinations **You may NOT be eligible if...** - You had a heart attack within the last 6 months - You have severe heart failure or uncontrolled heart disease - You produce large amounts of mucus daily - You have had previous lung surgery in the target area 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

PROCEDUREInterlobar fissure completion and pleural adhesiolysis

A video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT05257681


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