A Study of Disposable Transnasal Esophagoscope

Completed

• Conditions: Gastroesophageal Reflux; Esophageal Varices; Esophageal Disease

• Registration Number: NCT01360515
• Lead Sponsor: Yonsei University

Brief Summary

This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

Detailed Description

A disposable, transnasal esophagoscope, E.G. ScanTM was developed by IntroMedic Co. Ltd. (Seoul, Korea). This device was designed to allow patient to undergo endoscopy with minimum pain without sedation. This endoscopy system consists of thin probe with a CMOS camera, controller and simple display system. This system is light enough to carry and does occupy much space, and thus, it can be used at patient bed sides in intensive care units, in emergency rooms, and even in doctor's offices.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. aged 20 years or older
2. endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or non-cardiogenic chest pain, or known or suspected to have esophageal varices, infectious esophagitis, or other esophageal disease based on their medical history
3. a written informed consent form

Exclusion Criteria

1. history or symptoms of severe rhinitis and sinusitis
2. symptoms of acute respiratory inflammation at the time of examination
3. abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery
4. taking anticoagulants such as coumadin
5. patients for whom a EGD could not be performed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of