NCT00085852

Brief Summary

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

June 15, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 6, 2008

Status Verified

February 1, 2008

Enrollment Period

1.5 years

First QC Date

June 15, 2004

Last Update Submit

February 27, 2008

Conditions

Pulmonary Emphysema

Keywords

emphysemachronic obstructive pulmonary diseaselung volume reductionbronchoscopicbronchoscopybronchoscope

Outcome Measures

Primary Outcomes (1)

  • SAEs - Safety

    1 year post treatment

Secondary Outcomes (4)

  • PFTs

    12 weeks post treatment

  • Dyspnea

    12 weeks post treatment

  • Exercise capacity

    12 weeks post treatment

  • QOL

    12 weeks post treatment

Study Arms (1)

Single

EXPERIMENTAL

Treatment with BLVR

Biological: BLVR

Interventions

BLVRBIOLOGICAL

10 mL Hydrogel

Single

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced emphysema
  • Limited exercise capacity and persistent symptoms despite medical therapy
  • Age between 18 and 75
  • No significant heart, kidney or liver disease
  • Willingness and ability to tolerate bronchoscopy
  • No prior Lung Volume Reduction Surgery or Lung Transplantation
  • Screening test results indicating that the procedure is appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Caritas St Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

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

Pulmonary EmphysemaEmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John J. Reilly, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

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 15, 2004

First Posted

June 17, 2004

Study Start

April 1, 2005

Primary Completion

October 1, 2006

Study Completion

June 1, 2007

Last Updated

March 6, 2008

Record last verified: 2008-02

Locations

US(2)