Colorectal CancerPhase 3NCT01370928
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
A Phase 3 study testing Olympus PCF-Y0014-L and Standard colonoscope in people with Colorectal Cancer and Adenomas, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. Read more about this study
- Who is it for?
- Ages 54 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenomas
- What is being tested?
- Olympus PCF-Y0014-L and Standard colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Aug 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 54 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons included in the NordICC trial are eligible for inclusion
- For information about the NordICC trial see clinicaltrials.gov NCT00883792
Who cannot join
- Pregnancy
- Persons younger than 18 years
- Persons unable to comprehend the information given
- not possible to start the examination without prior administration of sedation/analgesics
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.
- Conditions
- Colorectal Cancer, Adenomas
- Being tested
- Olympus PCF-Y0014-L, Standard colonoscope
- Keywords
- Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas
- Medical subject headings
- Colorectal Neoplasms, Adenoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus PCF-Y0014-LDevice
Also called Olympus PCF-Y0014-L colonoscope
Screening colonoscopy with a prototype colonoscope
Standard colonoscopeDevice
Also called Olympus series 160 colonoscope
Screening colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Prototype colonoscope | Experimental | The new colonoscope to be tested Receives: Device: Olympus PCF-Y0014-L |
| Standard colonoscope | Active comparator | The standard colonoscope used world-wide today. Receives: Device: Standard colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients´ evaluation of pain and discomfort
Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.
Measured: 24 hours
Secondary outcomes (4)
Time used to reach the caecum
The time used to reach the caecum will be recorded with a stop watch during the procedure.
Measured: 1 hour
Need for sedation/analgesics during the colonoscopy procedure
If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.
Measured: 1 hour
Need to change to a different colonoscope to complete the procedure
If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.
Measured: 10 minutes
Caecum intubation rate
The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionAug 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 Colorectal CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Bretthauer, MD, Ph.d., Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370928
- Sponsor's protocol ID
- PCF-Y0014-L
- Status last verified
- Apr 2012
- First submitted
- 21 Mar 2011
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23.
PubMed 22622786
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01370928
- Acronym / sponsor ID
- PCF-Y0014-L
- Conditions
- Colorectal Cancer, Adenomas
- Keywords
- Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Jun 2011 (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 purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prototype colonoscope | Experimental | Device: Olympus PCF-Y0014-LThe new colonoscope to be tested |
| Standard colonoscope | Active comparator | Device: Standard colonoscopeThe standard colonoscope used world-wide today. |
Who may qualify
- Ages
- 54 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Persons included in the NordICC trial are eligible for inclusion
- For information about the NordICC trial see clinicaltrials.gov NCT00883792
Key exclusion criteria (4 listed)
- Pregnancy
- Persons younger than 18 years
- Persons unable to comprehend the information given
- not possible to start the examination without prior administration of sedation/analgesics
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 |
|---|---|---|
| Olympus PCF-Y0014-LAlso: Olympus PCF-Y0014-L colonoscopeScreening colonoscopy with a prototype colonoscope | Device | Prototype colonoscope |
| Standard colonoscopeAlso: Olympus series 160 colonoscopeScreening colonoscopy | Device | Standard colonoscope |
Primary outcome
Patients´ evaluation of pain and discomfort
Time frame: 24 hours
Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.
4 secondary outcomes
Time used to reach the caecum
Time frame: 1 hour
Need for sedation/analgesics during the colonoscopy procedure
Time frame: 1 hour
Need to change to a different colonoscope to complete the procedure
Time frame: 10 minutes
Caecum intubation rate
Time frame: 30 minutes
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 27 Apr 2012.
- Derived from this study: PubMed 22622786Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23.
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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.
Michael Bretthauer, MD, Ph.d. study chair
Oslo University Hospital
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 Olympus PCF-Y0014-L and Standard colonoscope in people with Colorectal Cancer and Adenomas, run by Sorlandet Hospital HF at 1 site in Norway.
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 4 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 27 Apr 2012. 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 Norway. 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?
Patients´ evaluation of pain and discomfort (time frame: 24 hours). 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 NCT01370928, 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 27 Apr 2012.