Post Market Registry Study of the AeriSeal System

November 13, 2013 updated by: Aeris Therapeutics
  • Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
  • Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

25

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

  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Donaustauf, Germany, 93093
        • Klinikum Donaustauf
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken Muenchen-Gauting
      • Halle, Germany, 06120
        • Universitätsklinikum Halle
      • Hamburg, Germany, 21075
        • Asklepios Klinik Hamburg-Harburg
      • Heidelberg, Germany, D-69126
        • Thoraxklinik am Uniklinikum Heidelberg
      • Luebeck, Germany, 23560
        • Sana Kliniken Luebeck
      • Nurnberg, Germany, 90419
        • Klinikum Nuerberg Nord
      • Solingen, Germany, 42699
        • Bethanien KH Solingen
  • Israel
      • Beer Sheeva, Israel, 84101
        • Soroka Medical Center
      • Petach Tikvah, Israel, 49100
        • Rabin Medical Center, Beilinson Campus

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

Patients must have been or will be treated with the AeriSeal System

Description

Inclusion Criteria:

  • Advanced Emphysema
  • AeriSeal System treatment

Exclusion Criteria:

  • have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
  • have had frequent COPD exacerbations within the past year
  • require mechanical ventilatory support
  • have a pretreatment DLCO < 20% predicted or > 60% predicted
  • have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
  • have giant bullae
  • have undergone lung transplantation, lung volume reduction surgery, or lobectomy
  • are intolerant of corticosteroids or antibiotics
  • are pregnant or breast-feeding

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
Post Market Registry Study of the AeriSeal System
Time Frame: At least 4 years
-Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting
At least 4 years

Collaborators and Investigators

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

Sponsor

Aeris Therapeutics

Investigators

  • Study Director: Janine McDermott, MS CCRP, 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

February 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 27, 2012

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-C12-001PLV

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.

Clinical Trials on Pulmonary Emphysema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe