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A Study of Disposable Transnasal Esophagoscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360515
First Posted: May 25, 2011
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

Condition
Gastroesophageal Reflux Esophageal Varices Esophageal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Disposable Transnasal Esophagoscope: a Prospective Pilot Trial of Feasibility, Safety and Tolerance

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 50
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360515


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Si Young Song, M.D., Ph.D. Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01360515     History of Changes
Other Study ID Numbers: 1-2010-0020
First Submitted: May 23, 2011
First Posted: May 25, 2011
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Yonsei University:
esophagoscope
esophageal disease
gastroesophageal reflux
esophageal varices

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal and Gastric Varices
Esophageal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases