First Colonoscopy ExaminationPhase 3NCT01142167
A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
A Phase 3 study testing Standard Colonoscopy and Ultra-thin colonoscopy in people with First Colonoscopy Examination, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Colonoscopy Examination
- What is being tested?
- Standard Colonoscopy and Ultra-thin colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,121 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First outpatient colonoscopy
- Able to provide informed consent
Who cannot join
- Unable to provide consent
- Prior colon surgery (except appendectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).
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.
Read the detailed 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.
- Conditions
- First Colonoscopy Examination
- Being tested
- Standard Colonoscopy, Ultra-thin colonoscopy
- Keywords
- Ultra-thin colonoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyProcedure or surgery
Standard colonoscopy will be used during colonoscopy
Ultra-thin colonoscopyProcedure or surgery
Ultra-thin colonoscope will be used during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy | Active comparator | Colonoscopy with standard instrument Receives: Procedure: Standard Colonoscopy |
| Ultra-thin colonoscopy | Experimental | New prototype scope Receives: Procedure: Ultra-thin colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Caecal intubation
Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
Measured: 12 weeks
Secondary outcomes (3)
Caecal intubation time
Caecal intubation time Ultra-thin colonsocope vs standard colonoscope
Measured: 12 weeks
Patient Satisfaction and Pain score
Patient tolerability Ultra-thin vs standard colonoscope
Measured: 12 weeks
Endoscopist satisfaction
Ease of use prototype scope vs standard colonoscope
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Colonoscopy ExaminationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- James Y Lau, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142167
- Sponsor's protocol ID
- UTC Study
- Status last verified
- Jul 2013
- First submitted
- 9 Jun 2010
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1.
PubMed 21963069
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).
- ClinicalTrials.gov ID
- NCT01142167
- Acronym / sponsor ID
- UTC Study
- Conditions
- First Colonoscopy Examination
- Keywords
- Ultra-thin colonoscope
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy | Active comparator | Procedure: Standard ColonoscopyColonoscopy with standard instrument |
| Ultra-thin colonoscopy | Experimental | Procedure: Ultra-thin colonoscopyNew prototype scope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First outpatient colonoscopy
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Unable to provide consent
- Prior colon surgery (except appendectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ColonoscopyStandard colonoscopy will be used during colonoscopy | Procedure or surgery | Standard Colonoscopy |
| Ultra-thin colonoscopyUltra-thin colonoscope will be used during colonoscopy | Procedure or surgery | Ultra-thin colonoscopy |
Primary outcome
Successful Caecal intubation
Time frame: 12 weeks
Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
3 secondary outcomes
Caecal intubation time
Time frame: 12 weeks
Patient Satisfaction and Pain score
Time frame: 12 weeks
Endoscopist satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Derived from this study: PubMed 21963069Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Y Lau principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Colonoscopy and Ultra-thin colonoscopy in people with First Colonoscopy Examination, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Caecal intubation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01142167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.