HealthNCT04847765
ANTERO-6 Cine-MRI Study
A study testing VIPUN Gastric Monitoring System prototype in people with Health, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- VIPUN Gastric Monitoring System prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Apr 2021to 30 Apr 2021
- Phase
- Interventional
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- At least 18 years old
- Male
- BMI between and including 18 and 30
- Understand and able to read Dutch
- In good health on the basis of medical history
Who cannot join
- Using any medication that might affect gastric function or visceral sensitivity
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any gastrointestinal surgery that could influence normal gastric function in the opinion of the Investigator
- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- Nasopharyngeal surgery in the last 30 days
Show all 13Show fewer
- History of thermal or chemical injury to upper respiratory tract or esophagus
- Current esophageal or nasopharyngeal obstruction
- Known coagulopathy
- Known esophageal varices
- Metal or other MRI incompatible implants
- Contra-indications for MR (checked by MR safety questionnaire)
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Procedural Feasibility to Combine and Compare Dynamic Magnetic Resonance Imaging and an Isovolumetric Intragastric Balloon to Assess Gastric Contractility in Healthy Adults
Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions.
However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.
Read more
Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.
To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.
The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.
- Conditions
- Health
- Being tested
- VIPUN Gastric Monitoring System prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPUN Gastric Monitoring System prototypeDevice
The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile.
The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| Combined pressure measurement and MRI | Experimental | Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI. Receives: Device: VIPUN Gastric Monitoring System prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of gastric contractions identified by means of the investigational medical device
Analysis software filters the pressure signal and identifies individual gastric contractions.
The exact time at which each contraction is detected within a 30-minute recording period is documented.
Measured: 30 minutes
Gastric contractions identified visually by an expert radiologist
The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start21 Apr 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847765
- Sponsor's protocol ID
- S65104
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Procedural Feasibility to Combine and Compare Dynamic Magnetic Resonance Imaging and an Isovolumetric Intragastric Balloon to Assess Gastric Contractility in Healthy Adults
- ClinicalTrials.gov ID
- NCT04847765
- Acronym / sponsor ID
- S65104
- Conditions
- Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions.
However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.
Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.
To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.
The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined pressure measurement and MRI | Experimental | Device: VIPUN Gastric Monitoring System prototypeGastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- At least 18 years old
- Male
- BMI between and including 18 and 30
- Understand and able to read Dutch
Key exclusion criteria (13 listed)
- Using any medication that might affect gastric function or visceral sensitivity
- Known / suspected current use of illicit drugs
- Known psychiatric or neurological illness
- Any gastrointestinal surgery that could influence normal gastric function in the opinion of the Investigator
- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
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 |
|---|---|---|
| VIPUN Gastric Monitoring System prototypeThe VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile. The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging. | Device | Combined pressure measurement and MRI |
Primary outcome
Time of gastric contractions identified by means of the investigational medical device
Time frame: 30 minutes
Analysis software filters the pressure signal and identifies individual gastric contractions. The exact time at which each contraction is detected within a 30-minute recording period is documented.
Gastric contractions identified visually by an expert radiologist
Time frame: 30 minutes
The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPUN Gastric Monitoring System prototype in people with Health, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 30 Sep 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of gastric contractions identified by means of the investigational medical device (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 30 Sep 2021.