ColoAssist vs. MEI

Study Overview
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Brief Summary
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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
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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.

Official Title
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ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial

Conditions
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Screening, Colorectal Cancer

Intervention / Treatment
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* Device: ColoAssist
* Device: MEI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colorectal cancer, Adenoma