Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

Any Symptom Requiring Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258531
• Other study ID #: STHF Gastro 01
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2005
• Last updated: July 27, 2006
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Any Symptom Requiring Colonoscopy

Intervention

Device:
• Olympus ScopeGuide®, 3-dimentional magnetic imager

Locations

Country	Name	City	State
Norway	Medical Outpatients dept, Sykehuset Telemark	Skien

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Telemark

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain experienced during colonoscopy
Secondary	Coecal intubation rate