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Completed

NCT Number: NCT01204970

Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.

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Key information

Conditions

Lung Transplantation Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.

In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.

In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referral for bronchoscopic investigation/sampling
  • informed consent signed
  • recent spirometric data

Exclusion criteria

  • sedated and/or ventilated patients
  • patients on ICU
  • patients under oral anticoagulation
  • co-existing lung disease
  • acute infectious pulmonary disease

Treatment and study plan

Primary outcomes

  1. morphometry

    Time frame: 90 - 180 - 360 - 540 - 720 days

    morpohometrical analysis at different time point after lung transplantation

Secondary outcomes

  1. adverse events

    Time frame: 90 - 180 - 360- 540- 720 days

    bleeding, pneumothorax, pleuritic chest pain during procedure

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2010
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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