CLE for Differential Diagnosis of IBD | NCT02238665

Studies
CLE for Differential Diagnosis of IBD

NCT02238665

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

105Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Endomicroscopy

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

Sep 2014

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

Oct 2009

Primary Completion Date

Apr 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Sep 9, 2014

First Submission Date that Met QC Criteria

Sep 11, 2014

First Posted Date

Sep 12, 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

Sep 11, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Not provided

Description Module

Brief Summary

Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.

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

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ulcerative colitis			Device: Endomicroscopy
Crohn's disease			Device: Endomicroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endomicroscopy	Device		Crohn's disease Ulcerative colitis

Measure	Description	Time Frame
Number of participants with IBD		4 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

equal or above 18 years of age
ability to provide written informed consent
well-established diagnosis of CD or UC

Exclusion Criteria:

history of IBD reclassification in the last 3 years
Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
inability to provide written informed consent
severe uncontrolled coagulopathy
impaired renal function
pregnancy or breast feeding
active gastrointestinal bleeding
known allergy to fluorescein
residence in institutions

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

Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative colitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helmut Neumann, Professor	University Hospital Erlangen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Erlangen		Erlangen		91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25521573	Derived	Tontini GE, Mudter J, Vieth M, Atreya R, Gunther C, Zopf Y, Wildner D, Kiesslich R, Vecchi M, Neurath MF, Neumann H. Confocal laser endomicroscopy for the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy. 2015 May;47(5):437-43. doi: 10.1055/s-0034-1391226. Epub 2014 Dec 18.

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases