US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
1 other identifier
interventional
6
1 country
2
Brief Summary
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 30, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMarch 6, 2008
February 1, 2008
6 months
June 30, 2006
February 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
1 week post treatment
SAEs - Safety of the treatment through Week 12.
12 weeks post procedure
Secondary Outcomes (7)
SAEs - Safety of the treatment through Week 48.
48 weeks post treatment
Evaluation of radiologic changes.
12 weeks post treatment
Improvement in exercise capacity.
12 weeks post treatment
Improvement in quality of life.
12 weeks post treatment
Decrease in trapped gas.
12 weeks post treatment
- +2 more secondary outcomes
Study Arms (1)
Single Treatment
EXPERIMENTALExperimental Treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Temple University Lung Center
Philadelphia, Pennsylvania, 19140, United States
Related Publications (1)
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. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
PMID: 12406835BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Study Start
June 1, 2006
Primary Completion
December 1, 2006
Study Completion
September 1, 2007
Last Updated
March 6, 2008
Record last verified: 2008-02