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

Not Applicable

Terminated

• Conditions: Colon Cancer
• Interventions: Other: Sham Software; Other: Colometer

• Registration Number: NCT01969292
• Lead Sponsor: Christopher Andrews

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Software	Sham Software	An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.
Colometer	Colometer	Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.

Primary Outcome Measures

Name	Time	Method
%Clear	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.

Secondary Outcome Measures

Name	Time	Method
Average withdrawal velocity	Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Ottawa Stool Score	Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.

Trial Locations

Locations (1)

Forzani&MacPhail Colon Cancer Screening Centre; 🇨🇦 Calgary, Alberta, Canada