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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01449175

Enrollment

Registered

2011-10-10

Start date

2011-01-31

Completion date

2013-11-30

Last updated

2013-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pulmonary Obstructive Disease, Emphysema

Keywords

AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction (PLVR), biologic lung volume reduction (BLVR), heterogeneous, homogeneous, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive

Brief summary

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.

Detailed description

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in number of Serious Adverse Events (SAE)	Weeks 48, 96, 120, 144 following treatment	Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety

Secondary

Measure	Time frame	Description
Change in Vital Signs	weeks 48, 96, 120, 144 following treatment	Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs
Change in Oxygen (O2) Use	Weeks 48, 96, 120, 144 following treatment	Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline.
Change in medications	week 48, 96, 120, 144 following treatment	Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.
Change in Pulmonary Function Tests (PFT)	Weeks 48, 96, 120, 144 following treatment	Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline
Change in notable radiology results	weeks 48, 96, 120, 144 following treatment	Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144.

Countries

Austria, France, Germany, Israel

Outcome results