NCT05257681 Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
| NCT ID | NCT05257681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Emphysema or COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2026-05-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-05-24 with a primary completion date of 2026-05-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.
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. * 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. Exclusion Criteria: * 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 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 bpm), Complex ventricular arrhythmia, sustained SVT. * PaCO2 greater than 50mmHg on room air at screening. * PaO2 less than 45mmHg on room air at screening.
Frequently Asked Questions
Who can join the NCT05257681 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Emphysema or COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05257681 currently recruiting?
Yes, NCT05257681 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beth Israel Deaconess Medical Center to inquire about joining.
Where is the NCT05257681 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05257681 clinical trial?
NCT05257681 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 20 participants.
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