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OpenTrials
Completed

NCT Number: NCT00258531

Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

* 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

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Key information

Conditions

Any Symptom Requiring Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Outpatients dept, Sykehuset Telemark

Skien, 3710, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olympus ScopeGuide®, 3-dimentional magnetic imager

Device

Primary outcomes

  1. Pain experienced during colonoscopy

Secondary outcomes

  1. Coecal intubation rate

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Registry information

Official study title

Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation

Important dates

Study start
2003
Study completion
2005
First posted
Nov 24, 2005
Registry last updated
Jul 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.