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

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01449175
• Other study ID #: 03-C11-001PLV
• Status: Terminated
• Phase: N/A
• First received: April 19, 2011
• Last updated: November 13, 2013
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Ministry of HealthAustria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pulmonary Obstructive Disease
• Emphysema
• Pulmonary Emphysema

Locations

Country	Name	City	State
Austria	Otto Wagner Spital Wien	Wein
France	Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice	Nice
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	LungenKlinik Hemer	Hemer
Germany	LMU Medizinische Klinik und Poliklinik Klinikum Großhadern	München
Israel	Soroka Medical Center	Beer Sheeva
Israel	Rabin Medical Center, Beilinson Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Countries where clinical trial is conducted

Austria,  France,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weeks 48, 96, 120, 144 following treatment	Yes
Secondary	Change in Vital Signs	Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs	weeks 48, 96, 120, 144 following treatment	No
Secondary	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.	Weeks 48, 96, 120, 144 following treatment	No
Secondary	Change in medications	Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.	week 48, 96, 120, 144 following treatment	No
Secondary	Change in Pulmonary Function Tests (PFT)	Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline	Weeks 48, 96, 120, 144 following treatment	No
Secondary	Change in notable radiology results	Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144.	weeks 48, 96, 120, 144 following treatment	No