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Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01969292
Enrollment
79
Registered
2013-10-25
Start date
2013-09-30
Completion date
2016-01-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

colonoscopy, quality assurance

Brief 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. 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.

Interventions

OTHERColometer

Real time software based image analysis tool.

OTHERSham Software

Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.

Sponsors

Christopher Andrews
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Patients: patients who are not categorized as normal risk

Design outcomes

Primary

MeasureTime frameDescription
%ClearMeasurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutesThis 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.

Secondary

MeasureTime frame
Average withdrawal velocityMeasurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Ottawa Stool ScoreMeasurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026