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

NCT ID: NCT04231721

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-02-28

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.

Conditions

Healthy; Colonic Motility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy controls

High Resolution Colonic Manometry and 3D-Transit system

Intervention Type: DEVICE

Measurement of colonic pressure changes and passage patterns in healthy.

Interventions

High Resolution Colonic Manometry and 3D-Transit system

Measurement of colonic pressure changes and passage patterns in healthy.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Janne Ladefoged Fassov

OTHER

Sponsor Role: lead

Responsible Party

Janne Ladefoged Fassov

Principle investigator, MD, Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Klaus Krogh, Professor

Role: STUDY_DIRECTOR

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Locations

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Countries

Denmark

Central Contacts

Ditte S Iversen, MD

Role: CONTACT

dittiver@rm.dk

+45 78453800

Janne Fassov, MD, Ph.D

Role: CONTACT

janfas@rm.dk

+45 78453800

Facility Contacts

Ditte S Iversen, MD

Role: primary

dittiver@rm.dk

+45 78453800

Other Identifiers

CIV-19-05-028726

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-43-19

Identifier Type: -

Identifier Source: org_study_id