ColoAssist vs. MEI

Colorectal Cancer Clinical Trial

Official title:

ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895504
• Other study ID #: ColoAssist
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: March 2, 2015
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 66 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Screening

Intervention

Device:
• ColoAssist
Screening colonoscopy with the test instrument
• MEI
Colonoscopy with Olympus colonoscopes and MEI guidance

Locations

Country	Name	City	State
Norway	SSHF Arendal	Arendal
Norway	SSHF Kristiansand	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal intubation rate	The ability to reach the cecum during colonoscopy	1 hour	No
Secondary	Cecal intubation time	Time to reach the cecum during colonoscopy	1 hour	No
Secondary	Adenoma detection rate	The proportion of participants in whom at least one adenoma is detected	1 hour	No
Secondary	Polyp detection rate	The proportion of participants in whom at least one polyp i detected	1 hour	No
Secondary	Pain	Participants will be asked to score discomfort or pain during and after colonoscopy	24 hours	No