NCT05257681Recruiting
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 15 Feb 2022
- Start date
- 24 May 2022
- Primary completion date
- 24 Dec 2026
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- COPD
- NCT number
- NCT05257681
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 24 May 2022 to the primary completion date, 24 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior lung transplant, LVRS, bullectomy, or lobectomy.
- 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).
Other illness
- Myocardial infarction within 6 months of screening.
- Decompensated heart failure.
- Resting bradycardia (\<50 bpm), Complex ventricular arrhythmia, sustained SVT.
Lab values
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
Other
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Clinically significant bronchiectasis.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.