Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
ID05257681

Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction

Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-13

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a new lung surgery technique called lung fissure completion with pleural adhesiolysis for patients with severe emphysema or COPD who have not improved after bronchoscopic lung volume reduction using endobronchial valves (EBVs). The goal is to see if this surgery can improve lung function and symptoms in patients who still have poor breathing and little volume reduction despite previous valve treatment. The study is a pilot clinical trial focused on this specific patient group with failed EBV therapy. Participants will undergo a video-assisted thoracoscopic surgery (VATS) or robotic procedure where the surgeon will complete the lung fissure and remove adhesions near the treated lung lobe. This involves anesthesia, small incisions, use of a surgical stapler to close lung tissue gaps, and managing any air leaks or complications. After surgery, patients will be closely monitored and receive standard postoperative care. Bronchoscopy will also be performed to examine and adjust the valves if needed. During the study, participants will have follow-up visits at 14 days and 3 months after surgery. Researchers will collect data from medical records including lung function tests, walking distance tests, CT scans, and questionnaires measuring quality of life and breathlessness. The main outcomes measured are the success of fissure completion, safety events, lung volume reduction, and improvements in breathing and quality of life. Participants will be observed for up to two years for these outcomes.

CONDITIONS

Brief Title

Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 less than 350ml after bronchoscopic lung volume reduction
  • Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction
  • Endobronchial valves are still in place
  • Willing and able to complete protocol required study follow-up assessments and procedures
Not Eligible

You will not qualify if you...

  • Clinically significant mucus production (greater than 4 tablespoons per day)
  • 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, lung volume reduction surgery, 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 greater than 45mmHg) or evidence or history of Cor Pulmonale
  • Left ventricular ejection fraction less than 40%
  • Resting bradycardia (less than 50 bpm), complex ventricular arrhythmia, sustained supraventricular tachycardia
  • Carbon dioxide level (PaCO2) greater than 50mmHg on room air at screening
  • Oxygen level (PaO2) less than 45mmHg on room air at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo video-assisted thoracic surgery or robotic interlobar lung fissure completion with pleural adhesiolysis to address failed bronchoscopic lung volume reduction.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - Up to 14 days

Participants are monitored with standard post-operative care including chest tube management and evaluation for air leaks or complications.

Approximately 1 to 2 visits (in-person)

Follow-up

Duration - 3 months

Participants attend follow-up visits to assess lung function, quality of life, and imaging results including CT scans, pulmonary function tests, and questionnaires.

2 visits at 14 days and 3 months (in-person)

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Employment and activity limitations among adults with chronic obstructive pulmonary disease--United States, 2013.

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Adnan Majid, Fayez Kheir, Daniel Alape...

https://pubmed.ncbi.nlm.nih.gov/31436607

Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.

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