Clinical trial for Emphysema or COPD
Official title Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
ClinicalTrials.gov ID: NCT05257681
What this study is testing
- What it's testing
- The study will see if stapling the lung fissures and removing adhesions by video‑assisted thoracoscopic surgery can improve outcomes after a failed bronchoscopic lung volume reduction.
- Who it's for
- Adults with severe emphysema or COPD who have already tried bronchoscopic lung volume reduction with endobronchial valves without success.
- What's involved
- Participants will have a video‑assisted thoracoscopic surgery where the surgeon staples the lung fissures and removes scar tissue, followed by clinic visits and tests to check lung function and health.
- Time commitment
- The trial involves the surgery day plus several follow‑up visits over a few months to monitor recovery and results.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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.
- Current pneumococcus vaccination.
- Current influenza vaccination.
You likely can't join if
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Decompensated 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.
See the full eligibility 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.
- Current pneumococcus vaccination.
- Current influenza vaccination.
- Target lung volume reduction \<350ml after bronchoscopic lung volume reduction (BLVR).
- Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR).
- Endobronchial valves (EBV) are still in place.
- Willing and able to complete protocol required study follow-up assessments and procedures.
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Decompensated 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...
- 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 bpm), Complex ventricular arrhythmia, sustained SVT.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.