A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Aeris Therapeutics54 enrolled

Overview

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pulmonary Obstructive Disease Emphysema

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Locations (8)

Otto Wagner Spital Wien

Wein, Austria

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

Nice, France

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Thoraxklinik Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Change in number of Serious Adverse Events (SAE)

Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety

Time frame: Weeks 48, 96, 120, 144 following treatment

Secondary Outcomes

Change in Vital Signs

Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs

Time frame: weeks 48, 96, 120, 144 following treatment

Change in Oxygen (O2) Use

Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline.

Time frame: Weeks 48, 96, 120, 144 following treatment

Change in medications

Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.

Time frame: week 48, 96, 120, 144 following treatment

Change in Pulmonary Function Tests (PFT)

Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline

Time frame: Weeks 48, 96, 120, 144 following treatment

Change in notable radiology results

Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144.

Time frame: weeks 48, 96, 120, 144 following treatment

Data from ClinicalTrials.gov

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