Clinical Trial

Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema

Study acronym: BREATHE-2
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim 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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-07-10; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2025-01-28
Status change: Not Yet Recruiting → Recruiting 2023-10-06
Trial Details
NCT Number NCT05949645
Lead Sponsor Apreo Health, Inc.
Conditions Emphysema or COPD
Enrollment 30 participants
Start Date 2023-08-15
Primary Completion 2024-10-08 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31