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ColoAssist vs. MEI

S

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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