ColoAssist vs. MEI

NCT ID: NCT01895504

Last Updated: 2015-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-07-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer; Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

ColoAssist

Screening colonoscopy with a new colonoscope with gradual stiffness

Group Type: EXPERIMENTAL

ColoAssist

Intervention Type: DEVICE

Screening colonoscopy with the test instrument

MEI

Screening colonoscopy with colonoscopes compatible with and guided by MEI

Group Type: ACTIVE_COMPARATOR

MEI

Intervention Type: DEVICE

Colonoscopy with Olympus colonoscopes and MEI guidance

Interventions

ColoAssist

Screening colonoscopy with the test instrument

Intervention Type: DEVICE

MEI

Colonoscopy with Olympus colonoscopes and MEI guidance

Intervention Type: DEVICE

Other Intervention Names

FujiFilm EC-590WI4; Olympus ScopeGuide

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kjetil K Garborg, MD

Role: PRINCIPAL_INVESTIGATOR

SSHF Kristiansand, Norway

Michael Bretthauer, PhD

Role: STUDY_CHAIR

University of Oslo

Locations

SSHF Arendal

Arendal, , Norway

SSHF Kristiansand

Kristiansand, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 28405331 (View on PubMed)

Other Identifiers

ColoAssist

Identifier Type: -

Identifier Source: org_study_id