Functional Disorders of StomachANTERO-AC-1NCT03500887
Monitoring Stomach Function With an Intragastric Balloon - a Pilot
A study testing intragastric bag in people with Functional Disorders of Stomach, run by Prof Dr Jan Tack at 1 site in Belgium.
Trial summary
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Disorders of Stomach
- What is being tested?
- intragastric bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2015to Feb 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are between 18-60 years old.
- Male and female.
- Patients must provide witnessed written informed consent prior to any study procedures being performed.
Who cannot join
- They are older than 60 years old.
- Have severely decreased kidney function.
- Have severely decreased liver function.
- Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- Have severe lung disease.
- Have severe psychiatric illness or neurological illness.
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- Have any gastrointestinal disease.
- Have any dyspeptic symptoms.
- Women that are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
- Conditions
- Functional Disorders of Stomach
- Being tested
- intragastric bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intragastric bagDevice
| Study group | Role | What they receive |
|---|---|---|
| 1. Bag inflated so that intrabagpressure increases with 2 mmHg | Other | Not described Receives: Device: intragastric bag |
| 2. Bag inflated to ¾ volume of 1 | Other | Not described Receives: Device: intragastric bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intragastric pressure during food intake
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
Measured: max 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startNov 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Disorders of StomachStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Dr Jan Tack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan Tack, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500887
- Sponsor's protocol ID
- S58484
- Acronym
- ANTERO-AC-1
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03500887
- Acronym / sponsor ID
- ANTERO-AC-1 / S58484
- Conditions
- Functional Disorders of Stomach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Prof Dr Jan TackUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Apr 2018 (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.
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Bag inflated so that intrabagpressure increases with 2 mmHg | Other | Device: intragastric bag |
| 2. Bag inflated to ¾ volume of 1 | Other | Device: intragastric bag |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- They are between 18-60 years old.
- Male and female.
- Patients must provide witnessed written informed consent prior to any study procedures being performed.
Key exclusion criteria (9 listed)
- They are older than 60 years old.
- Have severely decreased kidney function.
- Have severely decreased liver function.
- Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- Have severe lung disease.
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 |
|---|---|---|
| intragastric bag | Device | 1. Bag inflated so that intrabagpressure increases with 2 mmHg, 2. Bag inflated to ¾ volume of 1 |
Primary outcome
Intragastric pressure during food intake
Time frame: max 3 hours
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
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 18 Apr 2018.
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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.
Jan Tack, Prof. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intragastric bag in people with Functional Disorders of Stomach, run by Prof Dr Jan Tack 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 3 inclusion and 9 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 18 Apr 2018. 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?
Intragastric pressure during food intake (time frame: max 3 hours). 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 18 Apr 2018.