Viewing Study NCT01909518


Ignite Creation Date: 2025-12-25 @ 4:33 AM
Ignite Modification Date: 2026-02-20 @ 11:56 PM
Study NCT ID: NCT01909518
Status: UNKNOWN
Last Update Posted: 2013-07-26
First Post: 2013-07-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Detection of Early Esophageal Squamous Neoplasia
Sponsor: Shandong University
Organization:

Study Overview

Official Title: Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy
Status: UNKNOWN
Status Verified Date: 2013-07
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 aim of the present study:

1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.
2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy
Detailed Description: Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).

Study Oversight

Has Oversight DMC: True
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?: