HealthyNCT04231721
High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.
An observational study of Healthy and Colonic Motility, run by Janne Ladefoged Fassov at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Colonic Motility
- What is being tested?
- High Resolution Colonic Manometry and 3D-Transit system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age between 18 and 70
- Normal gastrointestinal function
- Psychologically able to give an informed content.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, Aarhus N, 8200
Ditte S Iversen, MD, +45 78453800, dittiver@rm.dk
About this study
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.
Read more
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
- Being tested
- High Resolution Colonic Manometry and 3D-Transit system
- Keywords
- Neurogastroenterology, Colonic motility, Manometry, High resolution colonic manometry, 3D-Transit system, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Colonic Manometry and 3D-Transit systemDevice
Measurement of colonic pressure changes and passage patterns in healthy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Device: High Resolution Colonic Manometry and 3D-Transit system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours measurement
Secondary outcomes (1)
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).
Measured: 24 hours measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janne Ladefoged Fassov
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Janne Ladefoged Fassov, Aarhus University Hospital
- Investigators
- Klaus Krogh, Professor, Study director, Department of Hepatology and Gastroenterology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231721
- Sponsor's protocol ID
- 1-10-72-43-19
- Other IDs
- CIV-19-05-028726
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the possibility of data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.
- ClinicalTrials.gov ID
- NCT04231721
- Acronym / sponsor ID
- 1-10-72-43-19
- Conditions
- Healthy, Colonic Motility
- Keywords
- Neurogastroenterology, Colonic motility, Manometry, High resolution colonic manometry, 3D-Transit system, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Janne Ladefoged FassovUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Device: High Resolution Colonic Manometry and 3D-Transit system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18 and 70
- Normal gastrointestinal function
- Psychologically able to give an informed content.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Resolution Colonic Manometry and 3D-Transit systemMeasurement of colonic pressure changes and passage patterns in healthy. | Device | Healthy controls |
Primary outcome
Correlation between pressure changes and passage patterns
Time frame: 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.
1 secondary outcome
Distance of capsule movement and pressure changes
Time frame: 24 hours measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided. Depending on the possibility of data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Krogh, Professor study director
Department of Hepatology and Gastroenterology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Colonic Motility, run by Janne Ladefoged Fassov at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ditte S Iversen, MD (+45 78453800, dittiver@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between pressure changes and passage patterns (time frame: 24 hours measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.