Colon CancerNCT01969292
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
A study testing Colometer in people with Colon Cancer, run by Christopher Andrews at 1 site in Canada.
Trial summary
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Colometer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jan 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta
- Endoscopists: Gastroenterologists with practices at the Forzani \& MacPhail Colon Cancer Screening Centre, Calgary, Alberta
Who cannot join
- Patients: patients who are not categorized as normal risk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Forzani&MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6
About this study
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.
- Conditions
- Colon Cancer
- Being tested
- Colometer, Sham Software
- Keywords
- colonoscopy, quality assurance
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColometerOther
Real time software based image analysis tool.
Sham SoftwareOther
Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Colometer | Experimental | Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist. Receives: Other: Colometer |
| Sham Software | Sham comparator | An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy. Receives: Other: Sham Software |
| Control | No intervention | Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
%Clear
This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.
Measured: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes
Secondary outcomes (2)
Average withdrawal velocity
Measured: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Ottawa Stool Score
Measured: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Stage 1 Complete; Stage 2 and 3 not pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Andrews
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Andrews, University of Calgary
- Investigators
- Christopher N Andrews, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969292
- Sponsor's protocol ID
- Col001
- Status last verified
- Jan 2016
- First submitted
- 26 Sep 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT01969292
- Acronym / sponsor ID
- Col001
- Conditions
- Colon Cancer
- Keywords
- colonoscopy, quality assurance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stage 1 Complete; Stage 2 and 3 not pursued
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Christopher AndrewsUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Oct 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.
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colometer | Experimental | Other: ColometerColometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist. |
| Sham Software | Sham comparator | Other: Sham SoftwareAn identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy. |
| Control | No intervention | –Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta
- Endoscopists: Gastroenterologists with practices at the Forzani \& MacPhail Colon Cancer Screening Centre, Calgary, Alberta
Key exclusion criteria (1 listed)
- Patients: patients who are not categorized as normal risk
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 |
|---|---|---|
| ColometerReal time software based image analysis tool. | Other | Colometer |
| Sham SoftwareSoftware that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy. | Other | Sham Software |
Primary outcome
%Clear
Time frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes
This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.
2 secondary outcomes
Average withdrawal velocity
Time frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Ottawa Stool Score
Time frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Results and safety
The study was stopped early (reason given: Stage 1 Complete; Stage 2 and 3 not pursued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
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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.
Christopher N Andrews, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colometer in people with Colon Cancer, run by Christopher Andrews 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Aug 2016. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Stage 1 Complete; Stage 2 and 3 not pursued). Results are not available in the source record.
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?
%Clear (time frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes). 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 19 Aug 2016.