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Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01635491
Collaborator
Motilis,Switzerland (Other)
20
Enrollment
1
Location
7
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2012
    Actual Study Completion Date :
    Nov 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Total gastrointestinal transit time in healthy subjects. [Three days from baseline visit]

    Secondary Outcome Measures

    1. Segmental transit times in healthy subjects [Three days from Baseline visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy Volunteer

    • Signed informed consent obtained

    • Fasted since midnight

    Exclusion Criteria:

    • Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital, Department of Hepato and Gastroenterolegy Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus
    • Motilis,Switzerland

    Investigators

    • Principal Investigator: AnneMette Haase, Ph.D Student, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01635491
    Other Study ID Numbers:
    • M-20100267
    First Posted:
    Jul 9, 2012
    Last Update Posted:
    Dec 7, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by University of Aarhus
    Gastrointestinal Motility
    Transit time

    Study Results

    No Results Posted as of Dec 7, 2012