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

NCT01969292 | Terminated

• 1 other identifier: Col001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

colonoscopy; quality assurance

Outcome Measures

Primary Outcomes (1)

• %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.

  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

  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.

Study Arms (3)

Colometer

EXPERIMENTAL

Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.

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.

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.

Interventions

Colometer OTHER

Real time software based image analysis tool.

Colometer

Sham Software OTHER

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

Sham Software

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients: patients who are not categorized as normal risk

Sponsors & Collaborators

• Christopher Andrews: lead

Study Sites (1)

Forzani&MacPhail Colon Cancer Screening Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Christopher N Andrews, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 25, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-01

Locations

CA (1)