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A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 3

Conditions

First Colonoscopy Examination

Treatments

Procedure: Standard Colonoscopy
Procedure: Ultra-thin colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01142167
UTC Study

Details and patient eligibility

About

The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.

Full description

Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.

Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.

A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.

This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.

Patients with prior colorectal surgery or previous colonoscopy were excluded.

Enrollment

1,121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • First outpatient colonoscopy
  • Able to provide informed consent

Exclusion criteria

  • Unable to provide consent
  • Prior colon surgery (except appendectomy)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

1,121 participants in 2 patient groups

Standard Colonoscopy
Active Comparator group
Description:
Colonoscopy with standard instrument
Treatment:
Procedure: Standard Colonoscopy
Ultra-thin colonoscopy
Experimental group
Description:
New prototype scope
Treatment:
Procedure: Ultra-thin colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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