Lung volume reduction using a new approach for emphysema treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.