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Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

Sponsor
Sykehuset Telemark (Other)
Overall Status
Completed
CT.gov ID
NCT00258531
Collaborator
(none)
360
Enrollment
1
Location
24
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2003
Study Completion Date :
Jun 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Pain experienced during colonoscopy []

Secondary Outcome Measures

  1. Coecal intubation rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Outpatients dept, Sykehuset Telemark Skien Norway 3710

Sponsors and Collaborators

  • Sykehuset Telemark

Investigators

  • Principal Investigator: Geir Hoff, MBChB PhD, Sykehuset Telemark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00258531
Other Study ID Numbers:
  • STHF Gastro 01
First Posted:
Nov 24, 2005
Last Update Posted:
Jul 28, 2006
Last Verified:
Jun 1, 2005

Study Results

No Results Posted as of Jul 28, 2006