ColonoscopySCOPE GUIDENCT01480830
The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
A study testing Magnetic Endoscopic Imaging (MEI) colonoscopy in people with Colonoscopy, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Magnetic Endoscopic Imaging (MEI) colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.
Who cannot join
- Inability or unwillingness to provide written informed consent.
- Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
- Colonoscopist not participating in trial.
- Current pregnancy.
- Cardiac pacemaker or any other type of implantable stimulator.
- Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.
This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.
We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.
- Conditions
- Colonoscopy
- Being tested
- Magnetic Endoscopic Imaging (MEI) colonoscopy
- Keywords
- Quality, indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Endoscopic Imaging (MEI) colonoscopyDevice
Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by
| Study group | Role | What they receive |
|---|---|---|
| Standard colonoscopy | No intervention | Not described |
| Magnetic endoscopic imaging colonoscopy | Experimental | Not described Receives: Device: Magnetic Endoscopic Imaging (MEI) colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation rate
Measured: baseline
Secondary outcomes (5)
Patient comfort
Measured: baseline
Amount of sedation required
Measured: baseline
Polyp detection rate
Measured: baseline
Use of abdominal compression
Measured: baseline
Insertion time
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald MacIntosh, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480830
- Sponsor's protocol ID
- NCT01480830
- Acronym
- SCOPE GUIDE
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2011
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT01480830
- Acronym / sponsor ID
- SCOPE GUIDE / NCT01480830
- Conditions
- Colonoscopy
- Keywords
- Quality, indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Nov 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.
Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.
This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.
We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard colonoscopy | No intervention | – |
| Magnetic endoscopic imaging colonoscopy | Experimental | Device: Magnetic Endoscopic Imaging (MEI) colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.
Key exclusion criteria (6 listed)
- Inability or unwillingness to provide written informed consent.
- Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
- Colonoscopist not participating in trial.
- Current pregnancy.
- Cardiac pacemaker or any other type of implantable stimulator.
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 |
|---|---|---|
| Magnetic Endoscopic Imaging (MEI) colonoscopyColonoscopy using the Scope Guide system (Olympus Canada Inc.) by | Device | Magnetic endoscopic imaging colonoscopy |
Primary outcome
Cecal intubation rate
Time frame: baseline
5 secondary outcomes
Patient comfort
Time frame: baseline
Amount of sedation required
Time frame: baseline
Polyp detection rate
Time frame: baseline
Use of abdominal compression
Time frame: baseline
Insertion time
Time frame: baseline
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 21 Aug 2024.
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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.
Donald MacIntosh, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Endoscopic Imaging (MEI) colonoscopy in people with Colonoscopy, run by Nova Scotia Health Authority at 1 site in Canada.
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 6 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 21 Aug 2024. 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 Canada. 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: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2024.