NCT00650559

Brief Summary

There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

2.5 years

First QC Date

March 28, 2008

Last Update Submit

March 28, 2008

Conditions

COPDEmphysema

Keywords

COPDEmphysemathorax enlargementLVRS

Outcome Measures

Primary Outcomes (1)

  • Improvement of FEV1

    1 year

Secondary Outcomes (1)

  • Improvement of exercise capacity

    1 year

Study Arms (1)

1

EXPERIMENTAL

Experimental surgical intervention.

Procedure: Chest wall enlargement

Interventions

Chest wall enlargementPROCEDURE

Widening sternotomy

Also known as: PEEK cages
1

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with end-stage emphysema and
  • Disabling dyspnea
  • GOLD III or IV
  • Residual volume \> 200% predicted
  • Total Lung capacity \> 120% predicted
  • RV/TLC \> 0.6
  • Resting CO2 \< 50 mmHg
  • diffusion capacity \> 20% predicted
  • age \< 70 years

You may not qualify if:

  • previous sternotomy
  • contraindication of general anesthesia
  • chronic treatment with corticosteroids
  • any tobacco use within 6 months
  • candidates for lung volume reduction surgery or lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Leuven

Leuven, Flanders, 3000, Belgium

Location

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

  • Marc Decramer, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

June 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

BE(1)