Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-04 @ 7:52 PM
Study NCT ID:
NCT02725034
Status:
UNKNOWN
Last Update Posted:
2016-03-31
First Post:
2016-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield
Detailed Description:
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: