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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy; Colonic Motility
• Intervention / Treatment: Device: High Resolution Colonic Manometry and 3D-Transit system

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ditte S Iversen, MD; Phone Number: +45 78453800; Email: dittiver@rm.dk
• Study Contact Backup: Name: Janne Fassov, MD, Ph.D; Phone Number: +45 78453800; Email: janfas@rm.dk

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Department of Hepatology and Gastroenterology, Aarhus University Hospital
      • Contact: Ditte S Iversen, MD; Phone Number: +45 78453800; Email: dittiver@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Device: High Resolution Colonic Manometry and 3D-Transit system; Measurement of colonic pressure changes and passage patterns in healthy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Janne Ladefoged Fassov
• Collaborators: Aalborg University Hospital
• Investigators: Study Director: Klaus Krogh, Professor, Department of Hepatology and Gastroenterology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Healthy; Manometry; Colonic motility; Neurogastroenterology; 3D-Transit system; High resolution colonic manometry
• Other Study ID Numbers: 1-10-72-43-19; CIV-19-05-028726 (Other Identifier: Danish Competent Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on the possibility of data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No