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Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

S

Sykehuset Telemark

Status and phase

Completed
Phase 4

Conditions

Any Symptom Requiring Colonoscopy

Treatments

Device: Olympus ScopeGuide®, 3-dimentional magnetic imager

Study type

Interventional

Funder types

Other

Identifiers

NCT00258531
STHF Gastro 01

Details and patient eligibility

About

  • 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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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