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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Questionnaires, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "In addition, during the same visit, health-related quality of life will be measured using the Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and dyspnea will be assessed with the self-reported modified Medical Research Council dyspnea scale (mMRC)."
  • "After completing these questionnaires and indexes, subjects will be randomized by an opaque envelope technique following a block 2-4 pattern to either Group 1 (Combined robotic or VATS-fissure completion and BLVR with EBVs) or Group 2 (Medical management)."
  • "The lobe will have been selected by the CT core laboratory based on imaging with computed tomography."
  • "TLVR will be assessed at 3 months using the CT scans performed on patients as part of their standard of care."
  • "Crossover Group After the patient allocated to the medical management, the arm is followed for 3 months, they will be offered the robotic or VATS fissure completion procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults ages 40 to 75 with severe COPD/emphysema, a lung disease that makes breathing hard, and incomplete gaps between lung sections. It tests whether surgery to close these gaps before placing small valves in the airways helps reduce unwanted airflow between lung sections. Researchers will check safety, breathing, and symptoms over 3 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 75 years old.
  • Have stable disease while taking less than 10 mg of prednisone daily, or an equal dose of a similar drug.
  • Have stopped smoking at least 4 months before screening and agree not to smoke during the study.
  • Have finished a supervised lung exercise program within 12 months, or still do regular follow-up exercises if it was longer ago.
  • Be up to date on the pneumococcal vaccine, which helps prevent some types of pneumonia.
  • Be up to date on the flu vaccine.
  • Be willing and able to complete study visits, tests, and procedures.

Who can't join

  • Tests show more than 95% complete separation between lung sections and no unwanted airflow between them.
  • Produce more than 4 tablespoons of mucus daily, or have significant bronchiectasis—damaged, widened airways.
  • Have certain heart problems, including a heart attack within 6 months, uncontrolled heart failure, weak heart pumping, certain abnormal heart rhythms, or high lung blood pressure or related heart damage.
  • Have had 3 or more episodes of pneumonia or 3 or more COPD flare-ups in the past year.
  • Have had a lung transplant, surgery to reduce lung size, removal of large lung air pockets, or removal of a lung section.
  • Cannot safely stop blood-thinning or clot-preventing medicines for 7 days.
  • Have breathing test results or blood oxygen or carbon dioxide levels outside the study's required ranges.
  • Walk less than 100 meters or more than 450 meters during a 6-minute walk test after lung rehabilitation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * \> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation. * Clinically significant (greater than 4 tablespoons per day) mucus production. * Myocardial infarction within 6 months of screening. * Uncontrolled congestive heart failure. * Three or more pneumonia episodes in last year. * Three or more COPD exacerbation episodes in the last year. * Prior lung transplant, LVRS, bullectomy, or lobectomy. * Clinically significant bronchiectasis. * Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days. * Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit). * Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit). * Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT. * Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening. * TLC less than 100% predicted (determined by body plethysmography at screening). * RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening). * DLCO less than 20% of the predicted value at screening. * Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening. * PaCO2 greater than 50mmHg on room air at screening. * PaO2 less than 45mmHg on room air at screening

Study sites (1)

MA