A Study of Disposable Transnasal Esophagoscope

NCT ID: NCT01360515

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Esophageal Varices Esophageal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Si Young Song, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2010-0020

Identifier Type: -

Identifier Source: org_study_id

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