Gastrointestinal Motility in Severe Ulcerative Colitis Ob... | NCT01745029

Studies
Gastrointestinal Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit

NCT01745029

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jan 7, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

Motilis-3D-transit

Countries

Denmark

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 2014

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

Apr 2013

Primary Completion Date

Apr 2014Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Dec 6, 2012

First Submission Date that Met QC Criteria

Dec 6, 2012

First Posted Date

Dec 7, 2012Estimated

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 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Name	Class
Motilis Medica A/S ,Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results obtained in remission.

The study is done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.

The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell investigators more about GI motility during and after severe inflammation.

Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal canal as a whole during and after severe illness.

The investigators expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. The investigators do not expect any drop out, but in case of drop out a new patient will be included.

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

20Estimated

Label	Type	Description	Intervention Names
Ulcerative Colitis			Device: Motilis-3D-transit

Name	Type	Description	Arm Group Labels	Other Names
Motilis-3D-transit	Device		Ulcerative Colitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in quiescent UC.		Three days from baseline visit

Secondary Outcomes

Measure	Description	Time Frame
Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in quiescent UC.		Three days from baseline

Other Outcomes

Measure	Description	Time Frame
Velocity of progression through the colonic segments in quiescent UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.		three days from baseline visit

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Severe Ulcerative colitis (modified Truelove and Witt score)
Signed informed consent obtained
Fasted since midnight

Exclusion Criteria:

Known GI related symptoms complaints or GI diseases
Swallowing disorders
Cancer or other life threatening diseases or conditions
Pregnancy or breast-feeding
Previous abdominal surgery
Abdominal diameter >140cm?
Drug abuse or alcoholism
Irregular bowel movements
Known cardiovascular or pulmonary diseases
Participation in any clinical study within the last 30 days
Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
Medication affecting GI motility
MRI within the next four weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from severe Ulcerative Colitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AnneMette Haase, ph.d student	Contact	+45 61658483		annemette.haase@ki.au.dk
Klaus Krogh, Professor	Contact	+45 2338 5937		klaukrog@rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Department of Hepato and Gastroenterolegy	Recruiting	Aarhus C		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided