Esophageal Motility Disease Screening in Patient With Sus... | NCT02478944

Studies
Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

NCT02478944

Sponsor

University Hospital Erlangen

Status

Unknown status

Last Update Posted

Jun 30, 2016Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Inflammatory Bowel Disease

Interventions

Manometry

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

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

Jun 29, 2016

Last Update Posted Date

Jun 30, 2016Estimated

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

Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy

Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.

Detailed Description

Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.

No other interventions are administered to participants during this study.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inflammatory bowel disease	Experimental	Patients with Crohn's disease and ulcerative colitis undergoing manometry	Device: Manometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manometry	Device	Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal	Inflammatory bowel disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings		1 year
Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Manometry findings (peristaltic amplitude values, mmHG) during therapy		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inflammatory bowel disease
Suspicion of inflammatory bowel disease

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Yes

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

Name	Role	Phone	Extension	Email
Francesco Vitali, MD	Contact			francesco.vitali@uk-erlangen.de

Overall Officials

Name	Affiliation	Role
Heinz Albrecht, MD	UK Erlangen	Study Director

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008365	Manometry

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided