Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377338
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2006-09-15
Brief Title:
Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALVEOLE
Brief Summary:
Fibered confocal fluorescence microscopy FCFM also referred to as Cell-Vizio MaunaKea Technologies France is a new technique that produces microscopic imaging in a living tissue through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm FCFM is able to produce dynamic high-resolution microimaging of the respiratory bronchiolar walls alveolar ducts and sacs in vivo during endoscopy a procedure termed as alveoscopy
The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases
The goals of this French Phase II trial are
to evaluate the tolerance of the alveoscopy
to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases
The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases
The goals of this French Phase II trial are
to evaluate the tolerance of the alveoscopy
to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases
Detailed Description:
The study will include 40 healthy smoker or non-smoker volunteers 20 patients with normal Chest CT scan and normal respiratory function tests and 90 patients with focal or diffuse peripheral lung diseases
The Alveoscopy will be performed under local anesthesia in awake patients during a standard bronchoscopy The Alveoscopy will be performed on one side of the bronchial tree left or right lung Two to ten separate bronchial areas will be explored in each patient depending on the pathology focal or diffuse and the underlying respiratory function
A continuous monitoring of the Oxygen saturation blood pressure EKG will be performed during the procedure A chest X-ray will be performed after the procedure to eliminate a pneumothorax
The morphometric parameters of the alveolar microstructure and their variability will be studied according to the age gender lung area explored smoking status in healthy volunteers and normal CT scan subjects as well as in patients with peripheral lung diseases
The Alveoscopy will be performed under local anesthesia in awake patients during a standard bronchoscopy The Alveoscopy will be performed on one side of the bronchial tree left or right lung Two to ten separate bronchial areas will be explored in each patient depending on the pathology focal or diffuse and the underlying respiratory function
A continuous monitoring of the Oxygen saturation blood pressure EKG will be performed during the procedure A chest X-ray will be performed after the procedure to eliminate a pneumothorax
The morphometric parameters of the alveolar microstructure and their variability will be studied according to the age gender lung area explored smoking status in healthy volunteers and normal CT scan subjects as well as in patients with peripheral lung diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALVEOLE | None | None | None |