Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487695
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2007-06-18
Brief Title:
Confocal Endomicroscopy for Barretts Esophagus
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Confocal Laser Endomicroscopy for Improved Diagnosis of Barretts Esophagus and Associated Neoplasia
Status:
COMPLETED
Status Verified Date:
2021-06
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:
CEBE
Brief Summary:
The purpose of this study is to determine if confocal laser endomicroscopy CLE can improve detection of Barretts esophagus dysplasia and early esophageal cancer
Detailed Description:
Barretts esophagus is a leading cause of esophageal adenocarcinoma Detection of dysplasia and early cancers in Barretts esophagus can be challenging time-consuming and expensive Small lesions may be difficult to detect with standard endoscopy protocols Confocal laser endomicroscopy CLE is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope For this study we are comparing confocal laser endomicroscopy CLE with targeted biopsies with standard endoscopy EGDand biopsy for Barretts esophagus to determine if CLE is more effective for detecting dysplasia and cancer
Participants with Barretts esophagus in this study undergo 1 CLE with targeted mucosal biopsies biopsy only taken if CLE shows abnormal tissue and 2 standard EGD with biopsies The order of procedures is randomized some patients have CLE first while others have standard EGD first
Participants with Barretts esophagus in this study undergo 1 CLE with targeted mucosal biopsies biopsy only taken if CLE shows abnormal tissue and 2 standard EGD with biopsies The order of procedures is randomized some patients have CLE first while others have standard EGD first
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