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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
COMPLETE-1 Trial 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.Check my eligibility
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.See study design
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.
COMPLETE-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
COMPLETE-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
COMPLETE-1 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.
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,010,420 Total Patients Enrolled
Pulmonx CorporationIndustry Sponsor
14 Previous Clinical Trials
1,212 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 75 years old.My lung scan shows nearly complete fissures and no collateral ventilation.I have severe lung damage that causes coughing and infections.I have received the flu vaccine.I cough up more than 4 tablespoons of mucus daily.I have had a heart attack in the last 6 months.My lung capacity test shows less severe emphysema.I cannot stop taking my blood thinners safely for a week.I can walk less than 100 meters or more than 450 meters in 6 minutes.Your carbon dioxide level is too high when breathing regular air during screening.I finished a lung rehab program within the last year or am continuing exercises if it was over a year ago.My heart's pumping ability is below 40%.I am taking less than 10mg of prednisone or its equivalent daily.Your blood oxygen level is very low when breathing normal air.My heart's ability to pump blood is not affected by high lung blood pressure.I have had a lung transplant or surgery to remove part of my lung.I have had 3 or more flare-ups of my COPD in the past year.I have heart failure that is not well-managed.Your lung function is less than what is expected for someone your age and size.Your lung function is very low, less than 20% of what is expected for someone your age and size.I am willing and able to follow the study's required check-ups and procedures.I have had pneumonia 3 or more times in the past year.You have a slow resting heart rate, frequent abnormal heartbeats, or sustained rapid heart rhythm.I have received the pneumococcus vaccine.Your lung function test shows that you have very low or very high airflow compared to what is expected for someone your age and size.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover group
- Group 2: Medical management group
- Group 3: Intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be eligible to participate in this experiment?
"This clinical trial is in search of 20 individuals with emphysema between the ages 40 and 75. Additionally, these prospective participants must: be on a stable 10 mg dose or less of prednisone; have abstained from smoking for at least 4 months prior to screening and remain smoke-free throughout the study duration; complete their initial pulmonary rehabilitation program within 12 months before baseline testing (or continue maintenance respiratory therapy if this period has already elapsed); receive vaccinations against pneumococcal disease and influenza; agree to fulfill all assessments/procedures required by protocol during follow-up visits."
Answered by AI
Is it currently possible to enroll in this clinical investigation?
"Indeed, the website clinicaltrials.gov indicates that this study is still recruiting participants since its initial posting on August 1st 2021 and latest update June 10th 2022. The trial requires enrollment of 20 patients at a single medical centre."
Answered by AI
How many subjects are actively participating in this experiment?
"Indeed, the information available on clinicaltrials.gov indicates that this medical trial is currently seeking participants to enroll. The study was initially posted in August 1st 2021 and has been updated as recently as June 10th 2022. 20 patients are needed from a single research centre."
Answered by AI
Is this experiment open to individuals aged fifty and above?
"As listed in the inclusion criteria, this trial is available to applicants between 40 and 75 years of age. Furthermore, there are 1 separate trials for minors below 18 and 29 studies open to adults over 65."
Answered by AI
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