Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01560910
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2012-03-20
Brief Title:
Detection of Minimal Change Esophagitis by I-scan
Sponsor:
arpa pungrasamee
Organization:
Maharaj Nakorn Chiang Mai Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-03
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:
None
Brief Summary:
Study design and objective The primary outcome of this prospective cohort study was to identify the endoscopic findings that have diagnostic value for the prediction of NERD minimal change esophagitis by using HD endoscopy with i-scan The secondary outcome was to evaluate the response to proton pump inhibitor PPI in GERD patients with or without minimal change esophagitis
Detailed Description:
Background and aims Majority of patients with gastro-esophageal reflux disease GERD were non-erosive reflux disease NERD High definition HD endoscopy with i-scan could enhance visualization of mucosal and vascular pattern and might identify changes that were invisible at standard endoscopy This study aimed to evaluate the endoscopic findings that may have diagnostic value for the prediction of NERD by using HD endoscopy with i-scan
Methods Patients with typical GERD symptoms and healthy control without GERD symptoms were included and 2 validated GERD questionnaires were completed The endoscopist was blinded to the presence of reflux symptoms and distal esophagus was examined using standard white light endoscopy followed by i-scan Mucosal morphology at squamocolumnar junction SCJ observed by i-scan were compared between GERD patients and controls
Methods Patients with typical GERD symptoms and healthy control without GERD symptoms were included and 2 validated GERD questionnaires were completed The endoscopist was blinded to the presence of reflux symptoms and distal esophagus was examined using standard white light endoscopy followed by i-scan Mucosal morphology at squamocolumnar junction SCJ observed by i-scan were compared between GERD patients and controls
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