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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT04801108
Status
Recruiting
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Conditions

  • Emphysema or COPD

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic or VATS lobar fissure completion — PROCEDURE
    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 — DEVICE
    Endobronchial valves will be placed in the target lobe after the fissure completion.

Study Details

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.

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Adnan Majid, MD FCCP
[email protected]
617 6328252
Adnan Majid, MD FCCP (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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