A Study of Disposable Transnasal Esophagoscope

Gastroesophageal Reflux Clinical Trial

Official title:

A Novel Disposable Transnasal Esophagoscope: a Prospective Pilot Trial of Feasibility, Safety and Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360515
• Other study ID #: 1-2010-0020
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: February 1, 2012
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases
• Esophageal Varices
• Gastroesophageal Reflux

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of,