Comparison of MR Enteroclysis and MRI With Per Oral Contr... | NCT00204165

Studies
Comparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.

NCT00204165

Sponsor

University of Oslo

Status

Unknown status

Last Update Posted

Sep 11, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Magnetic Resonance Imaging, Intestine Small, Crohn Disease.

Interventions

MRI of the small bowel

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

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 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

Sep 7, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same way as MRI Enteroclysis.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
MRI of the small bowel	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 18 years
known Crohns disease or strong suspicion.
need of a small bowel examination

Exclusion Criteria:

pregnant
electrolyte disturbances.
Any MRI contraindications.

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
Nils-Einar Kløw, Prof. MD	Ulleval Universitetssykehus	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ulleval Universitets sykehus		Kirkeveien 166	Oslo	0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided