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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04231721
• Other study ID #: 1-10-72-43-19
• Secondary ID: CIV-19-05-028726
• Status: Not yet recruiting
• Start date: February 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2020
• Source: University of Aarhus
• Contact: Ditte S Iversen, MD
• Phone: +45 78453800
• Email: dittiver[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Motility
• Healthy

Intervention

Device:
• High Resolution Colonic Manometry and 3D-Transit system
Measurement of colonic pressure changes and passage patterns in healthy.

Locations

Country	Name	City	State
Denmark	Department of Hepatology and Gastroenterology, Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
Janne Ladefoged Fassov	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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