Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emp… (NCT05949645) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema
Austria, Netherlands, United Kingdom30 participantsStarted 2023-08-15
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 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).
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥15% and ≤50% of predicted at screening
. Post-bronchodilator RV \> 180% predicted
. Post-bronchodilator RV/TLC ≥ 0.55 at screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4
Exclusion criteria
. Arterial blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
. DLCO \<20% at screening
. Steroid therapy of 10 mg prednisolone (prednisone) or more per day
. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
. Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
. Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
. Known or suspected history of pulmonary arterial hypertension with a PASP \> 50 mmHg on echocardiogram or mPAP \> 25 mmHg on a right heart catheterization