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

Christopher Andrews

Status: Terminated

Conditions: Colon Cancer

Treatments: Other: Colometer; Other: Sham Software

Study type: Interventional

Funder types: Other

Identifiers

NCT01969292

Col001

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

79 participants in 3 patient groups

Colometer

Experimental group

Description:

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

Treatment:

Other: Colometer

Sham Software

Sham Comparator group

Description:

An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.

Treatment:

Other: Sham Software

Control

No Intervention group

Description:

Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.