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Safety Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients with Advanced Emphysema - Article


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Emphysema

Pulmonary Emphysema 




Clinical Trial: Safety Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients with Advanced Emphysema

This study is currently recruiting patients.

Sponsored by: Aeris Therapeutics
Information provided by: Aeris Therapeutics

Purpose

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

Condition Treatment or Intervention Phase
Pulmonary Emphysema
 Procedure: Aeris BLVR Treatment
 Drug: Aeris BLVR Treatment
 Device: Aeris BLVR Treatment
Phase I

MedlinePlus related topics:  Emphysema

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: A Single-center, Non-blinded, Non-randomized, Non-controlled Phase 1 Trial Assessing the Safety of the Aeris Therapeutics Bronchoscopic Lung Volume Reduction (BLVR) System in Patients with Advanced Heterogeneous Emphysema

Further Study Details: 

Expected Total Enrollment:  6

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 reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Carol Fanning, RRT  617-732-6272    cfanning@partners.org 
John J. Reilly, MD,  Principal Investigator

Study chairs or principal investigators

John J. Reilly, MD,  Principal Investigator,  Brigham and Women's Hospital   

More Information

Publications

Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. Epub 2002 Oct 11.

Study ID Numbers:  C04-001; IRB Protocol # 2003-P-002171
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  June 15, 2004
ClinicalTrials.gov Identifier:  NCT00085852
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: December 9, 2005
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