Zephyr Valve System + Fissure Completion for Emphysema

(COMPLETE-1 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Heart failure, Bronchiectasis, Pneumonia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with severe COPD or emphysema. It combines a standard treatment, endobronchial valves (tiny devices placed in the airways), with a new surgical technique called fissure completion, which uses robotic or VATS methods to close gaps between lung sections. The goal is to determine if this combination reduces lung problems and improves breathing. Suitable candidates have COPD or emphysema, experience breathing difficulties, and continue to face these issues despite regular treatment. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to safely stop taking blood thinners or medications that affect platelets for 7 days.

What prior data suggests that this protocol is safe for patients with severe COPD/emphysema?

Research has shown that Zephyr endobronchial valves offer a safe option for individuals with severe emphysema, improving lung function and quality of life. However, some patients may experience side effects. Within 90 days, about 10.7% of patients experienced severe COPD flare-ups, and some developed pneumonia. The valves can also cause a collapsed lung, which is a known risk.

Regarding lung fissure completion, research suggests that both VATS (video-assisted thoracoscopic surgery) and robotic surgery are generally safe. This procedure closes gaps between lung sections to reduce unwanted airflow. Although specific risk data is limited, these surgeries are considered safe and feasible for individuals with severe emphysema.

Overall, both treatments have been studied and are tolerated by many patients, though potential risks exist. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zephyr Valve System combined with fissure completion for emphysema because it offers a minimally invasive option for patients with severe emphysema, particularly those with incomplete lobar fissures. Unlike traditional surgical options like lung volume reduction surgery, which can be quite invasive and require longer recovery times, this method involves placing endobronchial valves through a less invasive procedure. These valves help redirect airflow to healthier parts of the lung, improving breathing efficiency. This approach not only targets the mechanical aspect of emphysema by improving lung function but also has the potential to enhance patients' quality of life more quickly and with fewer risks compared to more invasive procedures.

What evidence suggests that this trial's treatments could be effective for emphysema?

Research has shown that endobronchial valves (EBVs), such as Zephyr valves, can significantly enhance lung function, exercise capacity, and quality of life for individuals with severe emphysema. Studies have found that these valves reduce hyperinflation (excess air in the lungs) and improve key outcomes for those with COPD, a lung disease that makes breathing difficult.

In this trial, some participants will undergo video-assisted thoracic surgery fissure completion and valve placement. This procedure uses video-assisted or robotic techniques to close gaps between lung sections, potentially enhancing the effect of EBVs. This approach is considered feasible and relatively safe. Meanwhile, other participants will initially receive maximal medical therapy before potentially crossing over to the intervention group. Combining these treatments could further improve lung function and alleviate symptoms in those with severe emphysema. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 40-75 with severe COPD/emphysema who have completed pulmonary rehab within the last year, are non-smokers for at least 4 months, and can follow study procedures. They must not have had certain lung surgeries or conditions like uncontrolled heart failure, significant mucus production, frequent COPD exacerbations, or very low walking ability.

Inclusion Criteria

I am between 40 and 75 years old.

Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration

I have received the flu vaccine.

Exclusion Criteria

My lung scan shows nearly complete fissures and no collateral ventilation.

I have severe lung damage that causes coughing and infections.

I cough up more than 4 tablespoons of mucus daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Evaluation and Randomization

Initial bronchoscopic evaluation and randomization to either surgical intervention or medical management

1 week

1 visit (in-person)

Surgical Intervention

Robotic or VATS inter-lobar fissure completion and EBV placement for selected patients

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pulmonary function testing

3 months

2 visits (in-person)

Crossover Option

Medical management group participants are offered the surgical intervention after the follow-up period

Optional

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial valves placement
• Robotic or VATS lobar fissure completion
• VATS lobar fissure completion

Trial Overview The trial tests if completing lung fissures using surgery (VATS/robotic) before placing endobronchial valves improves outcomes in emphysema treatment compared to standard valve placement alone. It aims to see if this approach better reduces diseased lung segments' ventilation.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 2 Interventions

COPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.

Group II: Crossover group Experimental Treatment 2 Interventions

Subjects allocated to the medical management group will be offered to crossover after the 3 months follow-up period. The same procedure as in the intervention group will be performed. Follow-up after surgery will be the same as in the intervention group.

Group III: Medical management group Active Control 1 Intervention

COPD patients with severe emphysema and incomplete lobar fissures will be placed on maximal medical therapy for 3 months. At the end of this 3 month period, patients will fill in an additional set of quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. New pulmonary function testing will be performed and crossover to the intervention group will be offered.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Pulmonx Corporation

Industry Sponsor

Trials

15

Recruited

1,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8743904/

Endobronchial Valve (Zephyr) Treatment in Homogeneous ... The present study showed clinically and statistically significant improvements in the hyperinflation (reduction in RV) and other important COPD outcomes in the ...

2. resmedjournal.com resmedjournal.com/article/S0954-6111(24)00113-6/fulltext

Optimizing clinical outcomes for bronchoscopic lung ... BLVR with endobronchial valves is an important treatment option in carefully selected patients with severe emphysema. •. With wide adoption of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S095461112400235X

Efficacy and safety of simultaneous combined Zephyr and ... The combined implantation of Zephyr and Spiration valves resulted in significant clinical and functional improvements with an acceptable risk profile.

4. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/07000/endobronchial_zephyr_valves_for_bronchoscopic_lung.57.aspx

Endobronchial Zephyr valves for bronchoscopic lung ... Zephyr valves may improve lung function, exercise capacity, and quality of life in patients suffering from severe emphysema.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0900928

A Randomized Study of Endobronchial Valves for ... Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms.

6. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-03069-6

Outcome and safety 90 days after combined airway valve ... Further, we recorded severe COPD exacerbations with (3.6%) and without pneumonia (7.1%) in 10.7% of patients within 90 days after completion of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12369822/

Endobronchial Zephyr valves for bronchoscopic lung ... Zephyr valves may improve lung function, exercise capacity, and quality of life in patients suffering from severe emphysema. However, the increased risk of ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180002B.pdf

summary of safety and effectiveness data (ssed) The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with ...