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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
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• Age 40 to 75 years.

• Stable with less than 10mg prednisone (or equivalent) daily.

• Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.

• Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.

• Current pneumococcus vaccination.

• Current influenza vaccination.

• Willing and able to complete protocol required study follow-up assessments and procedures.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 20
Treatments
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.
Sponsors
Collaborators: Pulmonx Corporation
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov