Gastrointestinal MotilityNCT01635491
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
An observational study of Gastrointestinal Motility and Total Gastrointestinal Transit Time, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility, Total Gastrointestinal Transit Time, Segmental Transit Time
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Healthy Volunteer
- Signed informed consent obtained
- Fasted since midnight
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Hepato and Gastroenterolegy
Aarhus, 8000
About this study
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.
Read more
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.
- Conditions
- Gastrointestinal Motility, Total Gastrointestinal Transit Time, Segmental Transit Time, Gastric Emptying
- Keywords
- Gastrointestinal Motility, Transit time
What is being measured
The primary outcome is the main question the study is designed to answer.
Total gastrointestinal transit time in healthy subjects.
Measured: Three days from baseline visit
Secondary outcomes (1)
Segmental transit times in healthy subjects
Measured: Three days from Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MotilityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Motilis,Switzerland
- Responsible party
- Sponsor
- Investigators
- AnneMette Haase, Ph.D Student, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635491
- Sponsor's protocol ID
- M-20100267
- Status last verified
- Dec 2012
- First submitted
- 26 Jun 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
- ClinicalTrials.gov ID
- NCT01635491
- Acronym / sponsor ID
- M-20100267
- Conditions
- Gastrointestinal Motility, Total Gastrointestinal Transit Time, Segmental Transit Time, Gastric Emptying
- Keywords
- Gastrointestinal Motility, Transit time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Motilis,Switzerland
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (3 listed)
- Healthy Volunteer
- Signed informed consent obtained
- Fasted since midnight
Key exclusion criteria (12 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total gastrointestinal transit time in healthy subjects.
Time frame: Three days from baseline visit
1 secondary outcome
Segmental transit times in healthy subjects
Time frame: Three days from Baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AnneMette Haase, Ph.D Student principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Motility and Total Gastrointestinal Transit Time, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total gastrointestinal transit time in healthy subjects. (time frame: Three days from baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012.