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

November 13, 2013 updated by: Aeris Therapeutics
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 Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wein, Austria, A-1140
        • Otto Wagner Spital Wien
  • France
      • Nice, France, 06002 Cedex 1
        • Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
  • Germany
      • Bad Berka, Germany, D-99437
        • Zentralklinik Bad Berka GmbH
      • Heidelberg, Germany, D-69126
        • Thoraxklinik Heidelberg
      • Hemer, Germany, D-58675
        • Lungenklinik Hemer
      • München, Germany, D-81377
        • LMU Medizinische Klinik und Poliklinik Klinikum Großhadern
  • Israel
      • Beer Sheeva, Israel, 84101
        • Soroka Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center, Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vital Signs
Time Frame: weeks 48, 96, 120, 144 following treatment
Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs
weeks 48, 96, 120, 144 following treatment
Change in Oxygen (O2) Use
Time Frame: 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.
Weeks 48, 96, 120, 144 following treatment
Change in medications
Time Frame: week 48, 96, 120, 144 following treatment
Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.
week 48, 96, 120, 144 following treatment
Change in Pulmonary Function Tests (PFT)
Time Frame: Weeks 48, 96, 120, 144 following treatment
Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline
Weeks 48, 96, 120, 144 following treatment
Change in notable radiology results
Time Frame: 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.
weeks 48, 96, 120, 144 following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aeris Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-C11-001PLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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