First in Human Study to Assess an Implant to Treat Severe Emphysema (NCT05854550) | Clinical Trial Compass
CompletedNot Applicable
First in Human Study to Assess an Implant to Treat Severe Emphysema
Australia48 participantsStarted 2023-05-05
Plain-language summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are:
Is it safe? Does it work?
Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥ 35 and ≤ 80 years old
✓. Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
✓. At least one target lobe with \> 35% destruction (percent of voxels with \< -950 Hounsfield units on CT)
✓. Post-bronchodilator ratio of FEV1/FVC \< 0.7 at screening
✓. Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening
✓. Post-bronchodilator RV \> 180% predicted
✓. Post-bronchodilator RV/TLC ≥ 0.55 at screening
✓. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4