NCT04231721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

January 14, 2020

Last Update Submit

January 17, 2020

Conditions

HealthyColonic Motility

Keywords

NeurogastroenterologyColonic motilityManometryHigh resolution colonic manometry3D-Transit systemHealthy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Distance of capsule movement and pressure changes

    24 hours measurement

Study Arms (1)

Healthy controls

Device: High Resolution Colonic Manometry and 3D-Transit system

Interventions

High Resolution Colonic Manometry and 3D-Transit systemDEVICE

Measurement of colonic pressure changes and passage patterns in healthy.

Healthy controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Study Officials

  • Klaus Krogh, Professor

    Department of Hepatology and Gastroenterology, Aarhus University Hospital

    STUDY DIRECTOR

Central Study Contacts

Ditte S Iversen, MD

CONTACT

+45 78453800dittiver@rm.dk

Janne Fassov, MD, Ph.D

CONTACT

+45 78453800janfas@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator, MD, Ph.D.

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

DK(1)