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Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
NCT04801108 · Beth Israel Deaconess Medical Center · Updated 13 April 2026
- What is being tested
- Robotic or VATS lobar fissure completion; Endobronchial valves placement
- For
- Emphysema or COPD
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 40 years to 75 years. About 20 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 1 Aug 2021, ends 1 Aug 2026. Registered 16 March 2021.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Beth Israel Deaconess Medical CenterBoston, Massachusetts, United States
