NCT01895504

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

July 4, 2013

Last Update Submit

March 2, 2015

Conditions

Colorectal CancerScreening

Keywords

ColonoscopyColorectal cancerAdenoma

Outcome Measures

Primary Outcomes (1)

  • Cecal intubation rate

    The ability to reach the cecum during colonoscopy

    1 hour

Secondary Outcomes (4)

  • Cecal intubation time

    1 hour

  • Adenoma detection rate

    1 hour

  • Polyp detection rate

    1 hour

  • Pain

    24 hours

Study Arms (2)

ColoAssist

EXPERIMENTAL

Screening colonoscopy with a new colonoscope with gradual stiffness

Device: ColoAssist

MEI

ACTIVE COMPARATOR

Screening colonoscopy with colonoscopes compatible with and guided by MEI

Device: MEI

Interventions

ColoAssistDEVICE

Screening colonoscopy with the test instrument

Also known as: FujiFilm EC-590WI4
ColoAssist
MEIDEVICE

Colonoscopy with Olympus colonoscopes and MEI guidance

Also known as: Olympus ScopeGuide
MEI

Eligibility Criteria

Age55 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Excluded from the ongoing screening trial (NCT 00883792)
  • Inability or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SSHF Arendal

Arendal, Norway

Location

SSHF Kristiansand

Kristiansand, 4604, Norway

Location

Related Publications (1)

  • Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.

    PMID: 28405331DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Kjetil K Garborg, MD

    SSHF Kristiansand, Norway

    PRINCIPAL INVESTIGATOR

  • Michael Bretthauer, PhD

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

NO(2)