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Completed

NCT Number: NCT01895504

ColoAssist vs. MEI

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.

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Key information

Conditions

Colorectal Cancer Adenoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Screening

Age range

55 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SSHF Arendal, Arendal, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ColoAssist

Device

Screening colonoscopy with the test instrument

Other names: FujiFilm EC-590WI4

MEI

Device

Colonoscopy with Olympus colonoscopes and MEI guidance

Other names: Olympus ScopeGuide

Primary outcomes

  1. Cecal intubation rate

    Time frame: 1 hour

    The ability to reach the cecum during colonoscopy

Secondary outcomes

  1. Cecal intubation time

    Time frame: 1 hour

    Time to reach the cecum during colonoscopy

  2. Adenoma detection rate

    Time frame: 1 hour

    The proportion of participants in whom at least one adenoma is detected

  3. Polyp detection rate

    Time frame: 1 hour

    The proportion of participants in whom at least one polyp i detected

  4. Pain

    Time frame: 24 hours

    Participants will be asked to score discomfort or pain during and after colonoscopy

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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