NCT00164996

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

February 17, 2012

Status Verified

September 1, 2005

Enrollment Period

6 years

First QC Date

September 10, 2005

Last Update Submit

February 16, 2012

Conditions

Dyspepsia

Keywords

upper endoscopylocal pharyngeal anaesthesiaultrathin endoscope

Outcome Measures

Primary Outcomes (1)

  • patient's tolerance and anxiety in visual analog scale (VAS) score

Secondary Outcomes (1)

  • patient's satisfaction; procedure time; complications

Interventions

Local pharyngeal anaesthesiaPROCEDURE
Ultrathin endoscopeDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18-70

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wilfred Lik-Man Mui, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 14, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2010

Last Updated

February 17, 2012

Record last verified: 2005-09

Locations

CN(1)