NCT00013156

Brief Summary

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

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

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Chronic Obstructive Pulmonary DiseaseEmphysema

Study Arms (1)

Arm 1

OTHER
Procedure: Effectiveness of Lung Reduction Therapy

Interventions

Effectiveness of Lung Reduction TherapyPROCEDURE
Arm 1

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of \>165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Huizenga HF, Ramsey SD, Albert RK. Estimated growth of lung volume reduction surgery among Medicare enrollees: 1994 to 1996. Chest. 1998 Dec;114(6):1583-7. doi: 10.1378/chest.114.6.1583.

    PMID: 9872192RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hugh F Huizenga, MD MPH

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

  • Stephan D. Fihn, MD MPH

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

March 1, 2000

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)