Testing a New Implant for Severe Emphysema

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

Recruiting N/A Interventional Study
Emphysema or COPD Emphysema COPD
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Pulmair Medical, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with severe emphysema to test a new implant. Participants will be evaluated for their suitability based on health criteria and undergo a baseline exam.

Are You a Good Fit for This Trial?
Rules you out α-1 Antitrypsin deficiencySevere lung cancerSubstance abuse disorder

You may be able to join if

  • I have been diagnosed with COPD or emphysema
  • I am at least 22 years old
  • My BMI is between 18 and 32
  • I can walk between 100 and 400 meters in 6 minutes
  • I have stable disease and take less than 10 mg of prednisone daily
  • I have not smoked for 4 months
  • My FEV1 is between 15% and 50% of the predicted value
  • I have at least 25% emphysema destruction in each lung

You may not be able to join if

  • I am currently in another clinical study involving surgery or treatment
  • I have a history of severe pneumonia requiring hospitalization in the past year
  • I have had a heart attack or unstable heart failure in the past 6 months
  • I cannot stop blood thinners for a week before the procedure
  • I have uncontrolled high blood pressure in the lungs
  • I have a current diagnosis of a major mental health disorder
  • I have a significant lung condition like bronchiectasis
  • I have any other health issues that would make me unsuitable for the trial

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

A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed Informed Consent. 2. Diagnosis of COPD/emphysema. 3. At least 22-years of age. 4. 18 ≤ BMI ≤ 32. 5. 6-minute walk Distance between 100-meters and 400-meters at baseline exam. 6. Stable disease with less than 10-mg prednisone (or equivalent) daily 7. Non-smoking for 4-m…
Contacts

VP Clincal Operations

858-369-0000

tkruger@pulmair.com

CONTACT

Clinical Study Manager

858-369-0000

mgil@pulmair.com

CONTACT