Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
NCT ID: NCT01635491
Last Updated: 2012-12-07
Study Results
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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COMPLETED
20 participants
OBSERVATIONAL
2012-04-30
2012-11-30
Brief Summary
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The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.
The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.
The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.
The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent obtained
* Fasted since midnight
Exclusion Criteria
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Subject has abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Subject's bowel movements are irregular
* Subject has known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Subject takes any medication affecting GI motility
* Subject having MRI within the next four weeks
18 Years
85 Years
ALL
Yes
Sponsors
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Motilis,Switzerland
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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AnneMette Haase, Ph.D Student
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital, Department of Hepato and Gastroenterolegy
Aarhus, , Denmark
Countries
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Other Identifiers
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M-20100267
Identifier Type: -
Identifier Source: org_study_id