Status:

COMPLETED

US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation

Lead Sponsor:

Aeris Therapeutics

Conditions:

Pulmonary Emphysema

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Detailed Description

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduc...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Advanced emphysema
  • Limited exercise capacity and persistent symptoms despite medical therapy
  • Age between 18 and 75
  • No significant heart, kidney or liver disease
  • Willingness and ability to tolerate bronchoscopy
  • No prior Lung Volume Reduction Surgery or Lung Transplantation
  • Screening test results indicating that the procedure is appropriate

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2007

    Estimated Enrollment :

    6 Patients enrolled

    Trial Details

    Trial ID

    NCT00085852

    Start Date

    April 1 2005

    End Date

    June 1 2007

    Last Update

    March 6 2008

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Brigham and Women's Hospital

    Boston, Massachusetts, United States, 02115

    2

    Caritas St Elizabeth's Medical Center

    Boston, Massachusetts, United States, 02135