A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorPulmair Medical, Inc.
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.
Eligibility criteria
Qualifiers
Signed Informed Consent.
Diagnosis of COPD/emphysema.
At least 22-years of age.
18 ≤ BMI ≤ 32.
Disqualifiers
1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
Large bullae encompassing greater than 30% of either lung
Insufficient landmarks to evaluate the CT study using the software as it is intended
All lobes are less than 25% parenchyma diseased (< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
Trial design
Treatments tested in this trial
- Implantable Artificial Bronchus
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov