Gastrointestinal Transit Times and Motility in Healthy Vo... | NCT01635491

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

NCT01635491

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 7, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Gastrointestinal Motility
Total Gastrointestinal Transit Time
Segmental Transit Time
Gastric Emptying

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jun 26, 2012

First Submission Date that Met QC Criteria

Jul 4, 2012

First Posted Date

Jul 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2012

Last Update Posted Date

Dec 7, 2012Estimated

Name	Class
Motilis,Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total gastrointestinal transit time in healthy subjects.		Three days from baseline visit

Secondary Outcomes

Measure	Description	Time Frame
Segmental transit times in healthy subjects		Three days from Baseline visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AnneMette Haase, Ph.D Student	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Department of Hepato and Gastroenterolegy		Aarhus		8000	Denmark