MedTrace Logo

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

NCT04231721 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-01-22

No results posted yet for this study

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.

Conditions

  • Healthy
  • Colonic Motility

Interventions

DEVICE

High Resolution Colonic Manometry and 3D-Transit system

Measurement of colonic pressure changes and passage patterns in healthy.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Janne Ladefoged Fassov

    lead OTHER

Principal Investigators

  • Klaus Krogh, Professor · Department of Hepatology and Gastroenterology, Aarhus University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231721 on ClinicalTrials.gov