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NCT00164996 Clinical Trial

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

Dyspepsia Clinical Trial

Official title:
Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00164996
Other study ID # CRE 2004.312
Secondary ID
Status Completed
Phase Phase 3
First received September 10, 2005
Last updated February 16, 2012
Start date September 2004

Study information
Verified date September 2005
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Aged between 18-70

Exclusion Criteria:

- Previous experience of upper endoscopy

- Allergy to local pharyngeal anaesthesia

- Patient requesting sedation during endoscopy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Local pharyngeal anaesthesia

Device:
• Ultrathin endoscope

Locations
Country Name City State
China The Chinese University of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary patient's tolerance and anxiety in visual analog scale (VAS) score
Secondary patient's satisfaction; procedure time; complications
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