Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema
NCT ID: NCT00716053
Last Updated: 2010-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
225 participants
INTERVENTIONAL
2008-12-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
NCT00347659
US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
NCT00515164
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
NCT00435253
Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
NCT00630227
US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
NCT00085852
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs-actually using the body's natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BLVR
BLVR
BLVR 20 mL
Saline
BLVR
BLVR 20 mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BLVR
BLVR 20 mL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aeris Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Clinical Dept.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01-C08-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.