TerminatedNot Applicable

Post Market Registry Study of the AeriSeal System

Germany, Israel25 participantsStarted 2012-02

Plain-language summary

* Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting; * Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.

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: * Advanced Emphysema * AeriSeal System treatment Exclusion Criteria: * have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis * have had frequent COPD exacerbations within the past year * require mechanical ventilatory support * have a pretreatment DLCO \< 20% predicted or \> 60% predicted * have a pretreatment FEV1 \< 20% predicted AND homogeneous emphysema * have giant bullae * have undergone lung transplantation, lung volume reduction surgery, or lobectomy * are intolerant of corticosteroids or antibiotics * are pregnant or breast-feeding

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

Post Market Registry Study of the AeriSeal System

Timeframe: At least 4 years

Trial details

NCT IDNCT01520064

SponsorAeris Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Pulmonary Emphysema trials