Innovation in Endobronchial Sampling

NCT ID: NCT02380326

Last Updated: 2018-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2021-12-31

Brief Summary

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Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.

Detailed Description

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The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.

Conditions

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Diffuse Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung transplant recipients

Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities

Advanced endoscopic imaging modalities

Intervention Type PROCEDURE

Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT

Diffuse intersitial lung disease

Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities

Advanced endoscopic imaging modalities

Intervention Type PROCEDURE

Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT

Interventions

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Advanced endoscopic imaging modalities

Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.
* Informed consent available
* Age \> 18
* FVC \> 50%pred
* DLCO \> 35%pred
* PaO2 \> 55 mmHg, pCO2 \< 45 mmHg (ambient air)

Exclusion Criteria

* Age \> 75
* Systolic arterial pressure in the pulmonary artery : PAPS \>40mmHg
* Platelet count \<100000/µl
* INR \> 1.4
* BMI \>30
* Diffuse bullous lung disease
* Active anti-platelet or anticoagulant treatment
* Active heart failure or unstable coronary heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Yserbyt Jonas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonas Yserbyt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Jonas Yserbyt, MD

Role: primary

+3216332211

Other Identifiers

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150302V02

Identifier Type: -

Identifier Source: org_study_id

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