Who may be eligible for this emphysema or COPD clinical trial?

Adults aged 40 to 75 years with severe emphysema or COPD who still have breathlessness and less than 350 ml lung volume reduction after valve treatment may be eligible. Participants must be nonsmokers for at least 4 months and able to complete study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this emphysema or COPD clinical trial?

Study-related care, including the surgical procedure, follow-up tests, and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 75Years

All Genders

ID05257681

Surgical Completion of Lung Fissures Using VATS for Patients with Severe Emphysema or COPD Who Did Not Benefit From Bronchoscopic Lung Volume Reduction

Q: What is lung fissure completion surgery studying for severe emphysema or COPD?

This trial is studying a surgical procedure called lung fissure completion with pleural adhesiolysis to help patients with severe emphysema or COPD who have not improved after bronchoscopic lung volume reduction with valves. Researchers want to see if this surgery can improve lung function and reduce breathlessness. The study is led by Beth Israel Deaconess Medical Center.

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

Participants Needed

Research Sites

N/A

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Fissure Completion Surgery (Investigational)	Current Standard Care (Best Practice)
What it is	A minimally invasive surgical procedure using video-assisted thoracoscopic or robotic techniques to complete interlobar fissures and remove pleural adhesions for patients who previously received endobronchial valves and had incomplete fissure or limited lung volume reduction.	Ongoing medical management, pulmonary rehabilitation, supplemental oxygen, and supportive care—including monitoring, inhaled therapies, and management of comorbidities—as established by international COPD guidelines.
Role in the trial	Primary intervention studied for its ability to achieve more complete lung volume reduction and improve symptoms after prior bronchoscopic therapy.	Established routine management offered to patients remaining symptomatic after lung volume reduction procedures, per guideline recommendations.
Primary use	Intended to restore fissure integrity and allow more effective lung volume reduction in patients who did not benefit fully from endobronchial valves.	Focuses on symptom relief, maximizing lung function, improving exercise capacity, and supporting quality of life in advanced COPD/emphysema.
How it is given or performed	Surgery is performed under general anesthesia using minimally invasive thoracoscopic or robotic techniques, targeting the fissure and performing adhesiolysis. The goal is to complete the fissure adjacent to the lobe treated with prior bronchoscopic valves.	Non-surgical management includes inhaled bronchodilators, corticosteroids, supplemental oxygen, pulmonary rehabilitation, and regular follow-up. Patients continue medical therapy and supportive care as indicated.
Evidence status	Ongoing clinical study; results for effectiveness, lung volume reduction success, and impact on symptoms are not yet established.	Medical management and supportive care are supported by strong evidence from guidelines and systematic reviews; pulmonary rehabilitation and inhaled therapies improve function and quality of life in advanced disease.
Important limitations	Risks of surgery may include complications such as infection, prolonged air leak, bleeding, or cardiopulmonary events. The approach is investigational and data on long-term outcomes are not yet available.	Medical management may not address underlying anatomical lung changes for patients who are not eligible for further lung volume reduction and remain symptomatic.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 40Years - 75Years

All Genders

Eligibility Criteria

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

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

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)