Zephyr Valve System for Severe Emphysema
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Recruiting
N/A
Interventional Study
Emphysema or COPD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for patients with severe emphysema or COPD. Participants will undergo a surgical procedure to improve lung function and then receive a specific valve treatment.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 40 and 75 years old.
- I have stable health and take less than 10mg of prednisone daily.
- I have not smoked for the past 4 months.
- I have completed a pulmonary rehabilitation program in the last 12 months.
- I have had the current pneumococcus vaccination.
- I have had the current influenza vaccination.
- I can follow the study requirements.
You may not be able to join if
- I have more than 95% fissure completion on my chest scan.
- I produce a lot of mucus daily.
- I had a heart attack in the last 6 months.
- I have uncontrolled heart failure.
- I have had 3 or more pneumonia episodes in the last year.
- I have had 3 or more COPD flare-ups in the last year.
- I have had a lung transplant or similar surgery.
- I have a heart condition or high blood pressure in my lungs.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
* Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to t…
Contacts
No contact information available.