High Resolution Colonic Manometry in Relation to 3D-Trans... | NCT04231721

Studies
High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.

NCT04231721

Sponsor

Janne Ladefoged Fassov

Status

Unknown status

Last Update Posted

Jan 22, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Healthy
Colonic Motility

Interventions

High Resolution Colonic Manometry and 3D-Transit system

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

ID	Type	Description	Link
CIV-19-05-028726	Other Identifier	Danish Competent Authority

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Estimated

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Jan 14, 2020

First Posted Date

Jan 18, 2020Actual

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

Jan 17, 2020

Last Update Posted Date

Jan 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Janne Ladefoged Fassov, Principle investigator, MD, Ph.D., Aarhus University HospitalSponsor-Investigator

Lead Sponsor

Janne Ladefoged FassovOTHER

Collaborators

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Background: Within recent years, new methods for detailed assessment of gastrointestinal (GI) motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. Before widespread use of capsule-based techniques (3D-Transit or others), the system needs to be validated by another method.

Study Objectives: The purpose of this study is to investigate weather pressure changes measured by HRCM correlate with passage patterns recorded by 3D-Transit. This has been assumed so far, but has never been further investigated.

Hypothesis: Movement of the electromagnetic 3D-Transit capsule within the colon correspond well with pressure changes determined with HRCM.

Materials and methods: HRCM and 3D-transit will be performed simultaneously in 20 healthy participants. A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system.

Perspectives: If data from the 3D-Transit technique correlate well with HRCM, the method provide a non-invasive alternative allowing detailed assessment of colonic motility.

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

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy controls			Device: High Resolution Colonic Manometry and 3D-Transit system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Resolution Colonic Manometry and 3D-Transit system	Device	Measurement of colonic pressure changes and passage patterns in healthy.	Healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between pressure changes and passage patterns	Do the high amplitude propagating contraction patterns accessed with High Resolution Colonic Manometry occur simultaneously with the long fast antegrade movements determined with the 3D-Transit system.	24 hours measurement

Secondary Outcomes

Measure	Description	Time Frame
Distance of capsule movement and pressure changes	How do the length of a pressure change measured by High Resolution Colonic Manometry correlate with the distance covered in long fast antegrade movements determined with the 3D-Transit system (cm).	24 hours measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 70
Normal gastrointestinal function
Psychologically able to give an informed content.

Exclusion Criteria:

Known gastrointestinal disease
Intake of medication with known effects on the movement patterns in the gastrointestinal system.
Pregnancy and lactation
Unable to follow the scheduled program in the trial due to mental illness or instability.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

All healthy individuals who meet the inclusion- and exclusion criteria can be enrolled in the study. The recruitment process will primarily take place through the Danish website "Forsoegspersoner.dk", which all Danish people have equal access to.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ditte S Iversen, MD	Contact	+45 78453800		dittiver@rm.dk
Janne Fassov, MD, Ph.D	Contact	+45 78453800		janfas@rm.dk

Overall Officials

Name	Affiliation	Role
Klaus Krogh, Professor	Department of Hepatology and Gastroenterology, Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatology and Gastroenterology, Aarhus University Hospital		Aarhus	Aarhus N	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Depending on the possibility of data sharing.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided