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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In addition, during the same visit, health-related quality of life will be measured using the Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and dyspnea will be assessed with the self-reported mMRC."
  • "Target lung volume reduction (TLVR) will be assessed at 3 months using the CT scans performed on patients as part of their standard of care."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests surgery for people with severe emphysema/COPD, a lung disease that makes breathing hard, whose lung valve treatment did not work well enough. Doctors use small cuts and a camera to staple gaps between lung sections and remove scar-like bands of tissue, to see if this improves results after valve treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 to 75.
  • Have a stable condition and take less than 10 mg of prednisone daily, or an equal dose of a similar medicine.
  • Have not smoked for at least 4 months before screening and agree not to smoke during the study.
  • Be up to date on pneumococcal and flu vaccines.
  • The treated lung area shrank by less than 350 mL after lung valve treatment.
  • Still have shortness of breath after valve treatment, with a score of 2 or more on the mMRC breathing scale.
  • Still have the lung valves in place.
  • Be willing and able to complete study follow-up tests and procedures.

Who can't join

  • Cough up more than 4 tablespoons of mucus a day, or have significant bronchiectasis—damaged, widened airways.
  • Had 3 or more bouts of pneumonia or 3 or more COPD flare-ups in the past year.
  • Had a lung transplant or surgery to reduce lung size, remove large air sacs, or remove a lung section.
  • Cannot safely stop blood-thinning or anti-clotting medicines for 7 days.
  • Had a heart attack in the past 6 months, or have heart failure that is not under control.
  • Have uncontrolled high blood pressure in lung arteries (top pressure over 45 mmHg), or current or past right-sided heart failure caused by lung disease, based on a heart ultrasound from the past 3 months.
  • Have a heart pumping level below 40% on a heart ultrasound from the past 3 months; a resting heart rate below 50 beats per minute; certain complex abnormal rhythms in the lower heart chambers; or a lasting fast rhythm starting in the upper chambers.
  • At screening, have blood carbon dioxide above 50 mmHg or blood oxygen below 45 mmHg while breathing room air.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA