Magnetic Endoscope Imaging in Single-balloon-enteroscopy | NCT02184754

Studies
Magnetic Endoscope Imaging in Single-balloon-enteroscopy

NCT02184754

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jan 29, 2015Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Magnetic Endoscope Imaging in Single-balloon-enteroscopy

Interventions

Magnetic endoscope imaging (MEI)

Countries

Germany

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

Jan 2015

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

Dec 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jul 4, 2014

First Posted Date

Jul 9, 2014Estimated

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

Jan 28, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. The MEI will be compared with x-ray which is still the current gold standard for scope navigation in small bowel enteroscopy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
MEI			Procedure: Magnetic endoscope imaging (MEI)

Name	Type	Description	Arm Group Labels	Other Names
Magnetic endoscope imaging (MEI)	Procedure		MEI	Olympus MAJ-Y0158

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of concordance of MEI- and x-ray-images	Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance	5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for enteroscopy

Exclusion Criteria:

contraindication for enteroscopy
patients with cardiac pacemaker or defibrillator
pregnancy

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

endoscopy unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar		München	Bavaria	81675	Germany