Back to resultsUltrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Local pharyngeal anaesthesia
Ultrathin endoscope
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring upper endoscopy, local pharyngeal anaesthesia, ultrathin endoscope
Eligibility Criteria
Inclusion Criteria: Aged between 18-70 Exclusion Criteria: Previous experience of upper endoscopy Allergy to local pharyngeal anaesthesia Patient requesting sedation during endoscopy
Sites / Locations
- The Chinese University of Hong Kong
Outcomes
Primary Outcome Measures
patient's tolerance and anxiety in visual analog scale (VAS) score
Secondary Outcome Measures
patient's satisfaction; procedure time; complications
Full Information
NCT ID
NCT00164996
First Posted
September 10, 2005
Last Updated
February 16, 2012
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164996
Brief Title
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
Official Title
Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
upper endoscopy, local pharyngeal anaesthesia, ultrathin endoscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Local pharyngeal anaesthesia
Intervention Type
Device
Intervention Name(s)
Ultrathin endoscope
Primary Outcome Measure Information:
Title
patient's tolerance and anxiety in visual analog scale (VAS) score
Secondary Outcome Measure Information:
Title
patient's satisfaction; procedure time; complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18-70
Exclusion Criteria:
Previous experience of upper endoscopy
Allergy to local pharyngeal anaesthesia
Patient requesting sedation during endoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred Lik-Man Mui, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
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