ColoAssist vs. MEI

ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial

Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Screening
• Intervention / Treatment: Device: ColoAssist; Device: MEI

Detailed Description

The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.

• Study Type: Interventional
• Enrollment (Actual): 475
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Arendal, Norway
    • SSHF Arendal
  • Kristiansand, Norway, 4604
    • SSHF Kristiansand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)

Exclusion Criteria:

• Excluded from the ongoing screening trial (NCT 00883792)
• Inability or unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ColoAssist; Screening colonoscopy with a new colonoscope with gradual stiffness	Device: ColoAssist; Screening colonoscopy with the test instrument; Other Names: FujiFilm EC-590WI4
Active Comparator: MEI; Screening colonoscopy with colonoscopes compatible with and guided by MEI	Device: MEI; Colonoscopy with Olympus colonoscopes and MEI guidance; Other Names: Olympus ScopeGuide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecal intubation rate	The ability to reach the cecum during colonoscopy	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecal intubation time	Time to reach the cecum during colonoscopy	1 hour
Adenoma detection rate	The proportion of participants in whom at least one adenoma is detected	1 hour
Polyp detection rate	The proportion of participants in whom at least one polyp i detected	1 hour
Pain	Participants will be asked to score discomfort or pain during and after colonoscopy	24 hours

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Investigators: Principal Investigator: Kjetil K Garborg, MD, SSHF Kristiansand, Norway; Study Chair: Michael Bretthauer, PhD, University of Oslo

Publications and helpful links

General Publications

• Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Adenoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ColoAssist