Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

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)