GastroparesisANTERO-AC-2NCT03441230
Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
A study testing Balloon characteristics in people with Gastroparesis, run by Prof Dr Jan Tack at 1 site in Belgium.
Trial summary
There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Balloon characteristics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2016to 20 Jan 2017
- 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 and younger than 18 years.
- They are taking medication.
- 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.
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- Have severe psychiatric illness or neurological illness.
- 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: ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.
- Conditions
- Gastroparesis
- Being tested
- Balloon characteristics
- Keywords
- stomach, motility
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon characteristicsDevice
Different size balloon
| Study group | Role | What they receive |
|---|---|---|
| Circumference of 13 cm, sphere form (diameter of 4 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 13 cm, cylinder form, length 11 cm | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 16 cm, sphere form (diameter of 5 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 16 cm, cylinder form, length 11 cm | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 16 cm, cylinder form, length 18 cm | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 19 cm, sphere form (diameter of 6 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 19 cm, cylinder form, length 11 cm | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 22 cm, sphere form (diameter of 7 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 25 cm, sphere form (diameter of 8 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
| Circumference of 28 cm, sphere form (diameter of 9 cm) | Active comparator | Not described Receives: Device: Balloon characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of distal stomach-induced contractions using various intragastric balloons
A comparison of various intragastric balloons for the assessment of gastric motility
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Feb 2016
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441230
- Sponsor's protocol ID
- S58817
- Acronym
- ANTERO-AC-2
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03441230
- Acronym / sponsor ID
- ANTERO-AC-2 / S58817
- Conditions
- Gastroparesis
- Keywords
- stomach, motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Prof Dr Jan TackUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 22 Feb 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.
There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Circumference of 13 cm, sphere form (diameter of 4 cm) | Active comparator | Device: Balloon characteristics |
| Circumference of 13 cm, cylinder form, length 11 cm | Active comparator | Device: Balloon characteristics |
| Circumference of 16 cm, sphere form (diameter of 5 cm) | Active comparator | Device: Balloon characteristics |
| Circumference of 16 cm, cylinder form, length 11 cm | Active comparator | Device: Balloon characteristics |
| Circumference of 16 cm, cylinder form, length 18 cm | Active comparator | Device: Balloon characteristics |
| Circumference of 19 cm, sphere form (diameter of 6 cm) | Active comparator | Device: Balloon characteristics |
| Circumference of 19 cm, cylinder form, length 11 cm | Active comparator | Device: Balloon characteristics |
| Circumference of 22 cm, sphere form (diameter of 7 cm) | Active comparator | Device: Balloon characteristics |
| Circumference of 25 cm, sphere form (diameter of 8 cm) | Active comparator | Device: Balloon characteristics |
| Circumference of 28 cm, sphere form (diameter of 9 cm) | Active comparator | Device: Balloon characteristics |
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 (10 listed)
- They are older than 60 years old and younger than 18 years.
- They are taking medication.
- 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.
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 |
|---|---|---|
| Balloon characteristicsDifferent size balloon | Device | Circumference of 13 cm, cylinder form, length 11 cm, Circumference of 13 cm, sphere form (diameter of 4 cm), Circumference of 16 cm, cylinder form, length 11 cm, Circumference of 16 cm, cylinder form, length 18 cm, Circumference of 16 cm, sphere form (diameter of 5 cm), Circumference of 19 cm, cylinder form, length 11 cm, Circumference of 19 cm, sphere form (diameter of 6 cm), Circumference of 22 cm, sphere form (diameter of 7 cm), Circumference of 25 cm, sphere form (diameter of 8 cm), Circumference of 28 cm, sphere form (diameter of 9 cm) |
Primary outcome
Detection of distal stomach-induced contractions using various intragastric balloons
Time frame: up to 1 year
A comparison of various intragastric balloons for the assessment of gastric motility
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 22 Feb 2018.
- Individual participant dataSharing planned: No
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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 Balloon characteristics in people with Gastroparesis, 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 10 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 22 Feb 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?
Detection of distal stomach-induced contractions using various intragastric balloons (time frame: up to 1 year). 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 Feb 2018.