About this trial
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent
Diagnosis of COPD/emphysema
At least 22-years of age
18 ≤ BMI ≤ 32
Disqualifiers
Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
α-1 Antitrypsin deficiency
Women of child-bearing potential
More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
Trial design
Single group
Treatments tested in this trial
Implantable pulmonary stent
DeviceImplantable polymer based pulmonary stent for severe COPD/emphysema
Treatment groups
Trial outcomes
Primary outcomes
Incidence of serious adverse events
The incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint.
Sponsors and contacts
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