Colorectal CancerNCT01895504
ColoAssist vs. MEI
A study testing ColoAssist and MEI in people with Colorectal Cancer and Screening, run by Sorlandet Hospital HF at 2 sites in Norway.
Trial summary
Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. Read more about this study
- Who is it for?
- Ages 55 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Screening
- What is being tested?
- ColoAssist and MEI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- 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 55 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)
Who cannot join
- Excluded from the ongoing screening trial (NCT 00883792)
- Inability or unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial
Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.
Read the detailed description
The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.
- Conditions
- Colorectal Cancer, Screening
- Being tested
- ColoAssist, MEI
- Keywords
- Colonoscopy, Colorectal cancer, Adenoma
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoAssistDevice
Also called FujiFilm EC-590WI4
Screening colonoscopy with the test instrument
MEIDevice
Also called Olympus ScopeGuide
Colonoscopy with Olympus colonoscopes and MEI guidance
| Study group | Role | What they receive |
|---|---|---|
| ColoAssist | Experimental | Screening colonoscopy with a new colonoscope with gradual stiffness Receives: Device: ColoAssist |
| MEI | Active comparator | Screening colonoscopy with colonoscopes compatible with and guided by MEI Receives: Device: MEI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation rate
The ability to reach the cecum during colonoscopy
Measured: 1 hour
Secondary outcomes (4)
Cecal intubation time
Time to reach the cecum during colonoscopy
Measured: 1 hour
Adenoma detection rate
The proportion of participants in whom at least one adenoma is detected
Measured: 1 hour
Polyp detection rate
The proportion of participants in whom at least one polyp i detected
Measured: 1 hour
Pain
Participants will be asked to score discomfort or pain during and after colonoscopy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJul 2014
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kjetil K Garborg, MD, Principal investigator, SSHF Kristiansand, NorwayMichael Bretthauer, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895504
- Sponsor's protocol ID
- ColoAssist
- Status last verified
- Mar 2015
- First submitted
- 4 Jul 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.
PubMed 28405331
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01895504
- Acronym / sponsor ID
- ColoAssist
- Conditions
- Colorectal Cancer, Screening
- Keywords
- Colonoscopy, Colorectal cancer, Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jul 2013 (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.
Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.
Detailed description
The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColoAssist | Experimental | Device: ColoAssistScreening colonoscopy with a new colonoscope with gradual stiffness |
| MEI | Active comparator | Device: MEIScreening colonoscopy with colonoscopes compatible with and guided by MEI |
Who may qualify
- Ages
- 55 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)
Key exclusion criteria (2 listed)
- Excluded from the ongoing screening trial (NCT 00883792)
- Inability or unwilling to provide informed consent
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 |
|---|---|---|
| ColoAssistAlso: FujiFilm EC-590WI4Screening colonoscopy with the test instrument | Device | ColoAssist |
| MEIAlso: Olympus ScopeGuideColonoscopy with Olympus colonoscopes and MEI guidance | Device | MEI |
Primary outcome
Cecal intubation rate
Time frame: 1 hour
The ability to reach the cecum during colonoscopy
4 secondary outcomes
Cecal intubation time
Time frame: 1 hour
Adenoma detection rate
Time frame: 1 hour
Polyp detection rate
Time frame: 1 hour
Pain
Time frame: 24 hours
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 4 Mar 2015.
- Derived from this study: PubMed 28405331Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 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.
Kjetil K Garborg, MD principal investigator
SSHF Kristiansand, Norway
Michael Bretthauer, PhD study chair
University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoAssist and MEI in people with Colorectal Cancer and Screening, run by Sorlandet Hospital HF at 2 sites 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 1 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Cecal intubation rate (time frame: 1 hour). 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 NCT01895504, 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 4 Mar 2015.