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

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.

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 data supports the effectiveness of the Zephyr Valve System + Fissure Completion treatment for emphysema?

Research shows that using Zephyr valves in patients with severe emphysema can significantly improve lung function and exercise capacity, as well as reduce symptoms. These benefits are seen particularly in patients without collateral ventilation, making the treatment promising for those with advanced emphysema. ^{1 2 3 4 5}

Is the Zephyr Valve System safe for humans?

The Zephyr Valve System has been studied for safety in patients with severe emphysema, showing some risks like procedure-related pneumothorax (collapsed lung), but no significant increase in chronic obstructive pulmonary disease exacerbations (worsening of symptoms). ^{1 2 3 4 6}

How is the Zephyr Valve System treatment for emphysema different from other treatments?

The Zephyr Valve System is unique because it involves placing small valves in the airways to block off damaged parts of the lung, allowing healthier areas to function better. This minimally invasive approach is different from traditional surgeries and is specifically beneficial for patients with severe emphysema without collateral ventilation, offering improvements in lung function and exercise capacity. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Bronchoscopic Lung Volume Reduction with Endobronchial Zephyr Valves for Severe Emphysema: A Systematic Review and Meta-Analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Long-Term Follow-Up Investigation of Endobronchial Valves in Emphysema (the LIVE Study): Study Protocol and Six-Month Interim Analysis Results of a Prospective Five-Year Observational Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bronchoscopic Lung Volume Reduction with Valves and Coils. A Network Meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). [2019]