Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-06-30

Brief Summary

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* A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
* No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier

Detailed Description

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Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.

Conditions

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Any Symptom Requiring Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Olympus ScopeGuide®, 3-dimentional magnetic imager

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A successive series of patients referred for routine colonoscopy

Exclusion Criteria

* Age under 18 years
* Pregnant women
* Persons with pacemaker
* Unwillingness to restrict sedation to "on demand"
* Inability to understand the information given

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Geir Hoff, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Telemark

Locations

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Medical Outpatients dept, Sykehuset Telemark

Skien, , Norway

Site Status

Countries

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Norway

Other Identifiers

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STHF Gastro 01

Identifier Type: -

Identifier Source: org_study_id