Evaluation of 3-Dimensional Magnetic Imaging During Colon... | NCT00258531

Studies
Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

NCT00258531

Sponsor

Sykehuset Telemark

Status

Completed

Last Update Posted

Jul 28, 2006Estimated

Enrollment

360

Phase

Phase 4

Conditions

Any Symptom Requiring Colonoscopy

Interventions

Olympus ScopeGuide®, 3-dimentional magnetic imager

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Nov 22, 2005

First Submission Date that Met QC Criteria

Nov 22, 2005

First Posted Date

Nov 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2006

Last Update Posted Date

Jul 28, 2006Estimated

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360

Name	Type	Description	Arm Group Labels	Other Names
Olympus ScopeGuide®, 3-dimentional magnetic imager	Device

Measure	Description	Time Frame
Pain experienced during colonoscopy

Measure	Description	Time Frame
Coecal intubation rate

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geir Hoff, MBChB PhD	Sykehuset Telemark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Outpatients dept, Sykehuset Telemark		Skien		3710	Norway