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

Terminated

• Conditions: Chronic Pulmonary Obstructive Disease; Emphysema

• Registration Number: NCT01449175
• Lead Sponsor: Aeris Therapeutics

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

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 homogeneous or heterogeneous emphysema.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Otto Wagner Spital Wien; 🇦🇹 Wein, Austria

Soroka Medical Center; 🇮🇱 Beer Sheeva, Israel

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petach Tikva, Israel

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany

LungenKlinik Hemer; 🇩🇪 Hemer, Germany

LMU Medizinische Klinik und Poliklinik Klinikum Großhadern; 🇩🇪 München, Germany