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Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

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Trial Conditions
  • Pulmonary Emphysema
What is the purpose of this trial?

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
40 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Clinical diagnosis of advanced heterogeneous emphysema

- Age >/= 40

- Clinically significant dyspnea

- Failure of standard medical therapy to relieve symptoms

- Pulmonary function tests with protocol-specified ranges

Exclusion Criteria:

- Alpha-1 protease inhibitor deficiency

- Tobacco use within 16 weeks of initial clinic visit

- Body mass index < 15 kg/m2 or > 35 kg/m@

- Clinically significant asthma, chronic bronchitis or bronchiectasis

- Allergy or sensitivity to tetracycline

- Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung
transplantation, prior endobronchial valve placement, prior airway stent placement or
prior pleurodesis

Gender: Both
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • BLVR System
Other Information

Sponsor: Aeris Therapeutics
Phase: Phase 1
Trial ID: NCT00347659
Volunteers:  Not Accepting Healthy Volunteers

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