Lung volume reduction using a new approach for emphysema treatment
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial
This study is testing a new surgery method that combines fixing lung fissures and placing valves to see if it helps people with severe emphysema feel better compared to regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04801108 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combined approach involving lung fissure completion and endobronchial valve placement in patients with severe COPD or emphysema. Participants will undergo either robotic or video-assisted thoracoscopic surgery to complete lung fissures, followed by the placement of endobronchial valves. The study aims to determine if this combined strategy improves patient outcomes compared to standard medical management. Approximately 20 patients will be enrolled at Beth Israel Deaconess Medical Center, with outcomes focusing on complications and physiological measurements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 75 with severe COPD or emphysema and less than 95% fissure completion.
Not a fit: Patients with more than 95% fissure completion or significant mucus production may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung function and quality of life for patients with severe emphysema.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.