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

NCT ID: NCT01745029

Last Updated: 2014-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative Colitis

Motilis-3D-transit

Intervention Type DEVICE

Interventions

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Motilis-3D-transit

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Motilis Medica A/S ,Switzerland

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Aarhus C, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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AnneMette Haase, ph.d student

Role: CONTACT

+45 61658483

Klaus Krogh, Professor

Role: CONTACT

+45 2338 5937

Facility Contacts

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AnneMette Haase, Ph.d Student

Role: primary

+45 6165 8483

Other Identifiers

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2012013250

Identifier Type: -

Identifier Source: org_study_id

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