NCT01895504

ColoAssist vs. MEI

ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Sorlandet Hospital HF · Other Government
• Sex: All
• Age: 55 Years – 66 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	ColoAssist	Screening colonoscopy with the test instrument
DEVICE	MEI	Colonoscopy with Olympus colonoscopes and MEI guidance

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-07-10
• Last updated: 2015-03-04

Locations

2 sites across 1 country: Norway