NCT00716053

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

July 15, 2008

Last Update Submit

January 14, 2010

Conditions

Advanced Upper Lobe Predominant Emphysema

Keywords

emphysemachronic obstructive pulmonary diseaseCOPDlung volume reductionLVRSBLVRAeris

Outcome Measures

Primary Outcomes (1)

  • Improvement in pulmonary function and respiratory symptoms

    6 months

Study Arms (2)

BLVR

EXPERIMENTAL
Drug: BLVR

Saline

SHAM COMPARATOR
Drug: BLVR

Interventions

BLVRDRUG

BLVR 20 mL

BLVRSaline

Sponsors & Collaborators

Related Publications (2)

  • 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

  • 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.

    PMID: 17426216BACKGROUND

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 18, 2010

Record last verified: 2010-01