ColoAssist vs. MEI

Sorlandet Hospital HF

Status: Completed

Conditions: Screening; Colorectal Cancer

Treatments: Device: ColoAssist; Device: MEI

Study type: Interventional

Funder types: Other

Identifiers

NCT01895504

ColoAssist

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 patients

Sex: All

Ages: 55 to 66 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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475 participants in 2 patient groups

ColoAssist

Experimental group

Description:

Screening colonoscopy with a new colonoscope with gradual stiffness

Treatment:

Device: ColoAssist

MEI

Active Comparator group

Description:

Screening colonoscopy with colonoscopes compatible with and guided by MEI

Treatment:

Device: MEI