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Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

NCT00630227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2011-10-24

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.

Conditions

  • Homogeneous Emphysema

Interventions

BIOLOGICAL

Biologic Lung Volume Reduction

20 mL Hydrogel

Sponsors & Collaborators

  • Aeris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Mark Gotfried, MD · Pulmonary Associates, Phoenix, AZ

  • Mark Dransfield, MD · University of Alabama, Birmingham, AL

  • Gerard Criner, MD · Temple University Lung Center, Philadelphia, PA

  • William Leeds, DO · Veritas Clinical Specialties, Topeka, KS

  • Mark Krasna, MD · St Josephs Medical Center, Towson, MD

  • Thomas Gildea, MD · Cleveland Clinic, Cleveland, OH

  • Sanjiv Tewari, MD · Akron Medical Center, Akron, OH

  • Geoffrey McLennan, MD · University of Iowa Hospitals & Clinics, Iowa City, IA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630227 on ClinicalTrials.gov