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

Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635491
• Other study ID #: M-20100267
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: December 6, 2012
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Emptying
• Gastrointestinal Motility
• Segmental Transit Time
• Total Gastrointestinal Transit Time

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Hepato and Gastroenterolegy	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Motilis,Switzerland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total gastrointestinal transit time in healthy subjects.		Three days from baseline visit	No
Secondary	Segmental transit times in healthy subjects		Three days from Baseline visit	No