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Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia

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ClinicalTrials.gov Identifier: NCT00164996
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
Chinese University of Hong Kong

Brief Summary:
The purpose of this study is to investigate whether an ultrathin endoscope will improve a patient's tolerance during the procedure. In addition, this study will look at whether local pharyngeal anaesthesia is necessary during ultrathin endoscopy.

Condition or disease Intervention/treatment Phase
Dyspepsia Procedure: Local pharyngeal anaesthesia Device: Ultrathin endoscope Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial
Study Start Date : September 2004
Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. patient's tolerance and anxiety in visual analog scale (VAS) score

Secondary Outcome Measures :
  1. patient's satisfaction; procedure time; complications


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18-70

Exclusion Criteria:

  • Previous experience of upper endoscopy
  • Allergy to local pharyngeal anaesthesia
  • Patient requesting sedation during endoscopy

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): NCT00164996


Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wilfred Lik-Man Mui, MD Chinese University of Hong Kong

ClinicalTrials.gov Identifier: NCT00164996     History of Changes
Other Study ID Numbers: CRE 2004.312
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: September 2005

Keywords provided by Chinese University of Hong Kong:
upper endoscopy
local pharyngeal anaesthesia
ultrathin endoscope

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs