Surgery-Plus-Valve combo aims to boost lung function in emphysema patients
NCT ID NCT04801108
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether completing the gaps between lung lobes with surgery before placing standard lung valves can improve outcomes for people with severe emphysema or COPD. About 20 participants will either receive the combined procedure or standard medical care. The goal is to see if this approach safely reduces trapped air and improves breathing and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Surgical fix offers new hope for failed emphysema treatment
- New lung implant aims to release trapped air in emphysema patients
- New lung implant aims to ease breathing for emphysema patients
- Lung valve registry shows promise for emphysema patients