Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00258531
First received: November 22, 2005
Last updated: July 27, 2006
Last verified: June 2005
  Purpose
  • 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 Intervention Phase
Any Symptom Requiring Colonoscopy
Device: Olympus ScopeGuide®, 3-dimentional magnetic imager
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation

Resource links provided by NLM:


Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Pain experienced during colonoscopy

Secondary Outcome Measures:
  • Coecal intubation rate

Estimated Enrollment: 360
Study Start Date: June 2003
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00258531     History of Changes
Other Study ID Numbers: STHF Gastro 01
Study First Received: November 22, 2005
Last Updated: July 27, 2006
Health Authority: Norway: Directorate of Health

ClinicalTrials.gov processed this record on July 20, 2014