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US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

NCT00435253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-10-24

No results posted yet for this study

Summary

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Conditions

  • Pulmonary Emphysema

Interventions

BIOLOGICAL

BLVR Treatment

BLVR Treatment, 10 mL Hydrogel

Sponsors & Collaborators

  • Aeris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Victor Pinto-Plata, MD · Steward St. Elizabeth's Medical Center of Boston, Inc.

  • Gerard Criner, MD · Temple University Lung Center

  • Mark Gotfried, MD · Pulmonary Associates

  • Charlie Strange, MD · Medical Univ South Carolina Hospital

  • Mark Dransfield, MD · Univ of Alabama Birmingham Lung Health Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT00435253 on ClinicalTrials.gov