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Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

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ClinicalTrials.gov Identifier: NCT00258531
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : July 28, 2006
Sponsor:
Information provided by:
Sykehuset Telemark

Brief Summary:
  • 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

Condition or disease Intervention/treatment Phase
Any Symptom Requiring Colonoscopy Device: Olympus ScopeGuide®, 3-dimentional magnetic imager Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation
Study Start Date : June 2003
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources




Primary Outcome Measures :
  1. Pain experienced during colonoscopy

Secondary Outcome Measures :
  1. Coecal intubation rate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258531


Locations
Norway
Medical Outpatients dept, Sykehuset Telemark
Skien, Norway, 3710
Sponsors and Collaborators
Sykehuset Telemark
Investigators
Principal Investigator: Geir Hoff, MBChB PhD Sykehuset Telemark

ClinicalTrials.gov Identifier: NCT00258531     History of Changes
Other Study ID Numbers: STHF Gastro 01
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: June 2005