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

• Conditions: Healthy; Colonic Motility
• Interventions: Device: High Resolution Colonic Manometry and 3D-Transit system

• Registration Number: NCT04231721
• Lead Sponsor: Janne Ladefoged Fassov

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 available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-17
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-22
• Study Start: 2020-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	High Resolution Colonic Manometry and 3D-Transit system	-

Primary Outcome Measures

Name	Time	Method
Correlation between pressure changes and passage patterns	24 hours measurement	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.

Secondary Outcome Measures

Name	Time	Method
Distance of capsule movement and pressure changes	24 hours measurement	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).

Trial Locations

Locations (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark