CompletedNot Applicable

Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema

Germany, Netherlands14 participantsStarted 2021-06-23

Plain-language summary

Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.

Who can participate

Age range

40 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

. Diagnosis of COPD
. FEV1/FVC ≤ 70%
. ≥ 40 years of age
. Post-bronchodilator FEV1 ≤ 45% of predicted
. Total Lung Capacity \> 100% of predicted
. Residual Volume (RV) \> 175% of predicted
. RV/TLC \> 55%
. Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4

Exclusion criteria

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.

What they're measuring

Safety: type and frequency of device-related and procedure-related AE

Timeframe: 3 months

Procedural succes

Timeframe: 3 months

Trial details

NCT IDNCT04520152

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-08

View on ClinicalTrials.gov More Emphysema or COPD trials