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A Study of Disposable Transnasal Esophagoscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01360515
First received: May 23, 2011
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 College of Medicine
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01360515     History of Changes
Other Study ID Numbers: 1-2010-0020
Study First Received: May 23, 2011
Last Updated: February 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on June 17, 2013