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Device

Zephyr Valve System + Fissure Completion for Emphysema (COMPLETE-1 Trial)

N/A

Recruiting

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40 to 75 years

Current influenza vaccination

Must not have

Clinically significant bronchiectasis

Clinically significant (greater than 4 tablespoons per day) mucus production

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study whether a new strategy for treating COPD, which involves sealing off open areas between lobes of the lungs, improves outcomes compared to the standard treatment of placing valves in the lungs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from surgical procedures such as pain, bleeding, infection risk increase; respiratory issues due to changes in lung function; and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 75 years old.

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I have received the flu vaccine.

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I am taking less than 10mg of prednisone or its equivalent daily.

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I have received the pneumococcus vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe lung damage that causes coughing and infections.

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I cough up more than 4 tablespoons of mucus daily.

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My lung capacity test shows less severe emphysema.

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I can walk less than 100 meters or more than 450 meters in 6 minutes.

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

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I have had a heart attack in the last 6 months.

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I have had a lung transplant or surgery to remove part of my lung.

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I have had 3 or more flare-ups of my COPD in the past year.

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I have heart failure that is not well-managed.

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I have had pneumonia 3 or more times in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of severe adverse events

Prove that inter-lobar fissures can be completed to at least 95% via robotic thoracic surgery or VATS in severe emphysema patients

Prove that patients consented for the procedure will ultimately undergo the intervention

Secondary study objectives

Percentage of patients to achieve target lung volume reduction

Percentage of patients with quality of life improvement

Percentage of patients with significant changes in pulmonary function testing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment2 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 groupExperimental Treatment2 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 groupActive Control1 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.

0 / 14Eligibility criteria met