HealthyANTERO-1NCT03239821
Clinical Evaluation of the VIPUN Balloon Catheter 0.1
A study testing VIPUN Balloon Catheter 0.1 deflated, Codeine Phosphate and VIPUN Balloon Catheter 0.1 inflated in people with Healthy and Motility Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Motility Disorder, Gastric Emptying
- What is being tested?
- VIPUN Balloon Catheter 0.1 deflated, Codeine Phosphate and VIPUN Balloon Catheter 0.1 inflated
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2017to 30 Apr 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Aged between and including 18 and 65 years
- BMI between and including 18 and 25
- Understand and able to read Dutch
- In good health on the basis of medical history
- Able to return home without driving a vehicle on visit days 1-4
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- Will not operate machines on the same day of treatment (visits 1-4)
- Females subjects of childbearing potential are willing to use adequate contraception
- Refrains from herbal, vitamin and other dietary supplements on the day of the visits
Who cannot join
- Exclusion criteria related to possible influence on end-points:
- Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- 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
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- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- Nasopharyngeal, upper GI or esophageal surgery in the last 30 days
- Suspected basal skull fracture or severe maxillofacial trauma
- History of thermal or chemical injury to upper respiratory tract or esophagus
- Current esophageal or nasopharyngeal obstruction
- Known coagulopathy
- Known esophageal varices
- History of opioid dependency
- Known severely decreased kidney or liver function
- Pregnant or breastfeeding women (pregnancy test will be performed on females with childbearing potential)
- Known severe lung disease (e.g. asthma or emphysema)
- Have known side-effects/allergic reactions when taking codeine/morphine
- Known diabetic, fructose intolerance or malabsorption of glucose or galactose or sucrose-isomalase insufficiency.
- Exclusion criteria related to Sirupus simplex administration:
- Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and methyl- and propylparahydroxybenzoate
- Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility
The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.
- Conditions
- Healthy, Motility Disorder, Gastric Emptying
- Being tested
- VIPUN Balloon Catheter 0.1 deflated, Codeine Phosphate, Placebo, VIPUN Balloon Catheter 0.1 inflated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPUN Balloon Catheter 0.1 deflatedDevice
deflation balloon
Codeine PhosphateDrug
58.8 mg codeïne phosphate
PlaceboDrug
Sirupus Simplex
VIPUN Balloon Catheter 0.1 inflatedDevice
VIPUN Balloon Catheter 0.1 inflated
| Study group | Role | What they receive |
|---|---|---|
| Placebo - deflated balloon | Sham comparator | Not described Receives: Device: VIPUN Balloon Catheter 0.1 deflated; Drug: Placebo |
| Placebo - inflated balloon | Placebo comparator | Not described Receives: Drug: Placebo; Device: VIPUN Balloon Catheter 0.1 inflated |
| Codeine - delfated balloon | Active comparator | Not described Receives: Device: VIPUN Balloon Catheter 0.1 deflated; Drug: Codeine Phosphate |
| Codeine - inflated balloon | Active comparator | Not described Receives: Drug: Codeine Phosphate; Device: VIPUN Balloon Catheter 0.1 inflated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.
Incidence, frequency, severity, seriousness and relatedness of AEs
Measured: 8 hours
Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.
Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)
Measured: 8 hours
Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.
Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)
Measured: 8 hours
Secondary outcomes (2)
Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon
To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.
Measured: 8 hours
Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)
To explore whether there is a correlation between gastric motility and emptying.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start25 Sep 2017
- Primary completion27 Mar 2018
- Study completion30 Apr 2018
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 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
- NCT03239821
- Sponsor's protocol ID
- S60320
- Acronym
- ANTERO-1
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 4 May 2018
- 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 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility
- ClinicalTrials.gov ID
- NCT03239821
- Acronym / sponsor ID
- ANTERO-1 / S60320
- Conditions
- Healthy, Motility Disorder, Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 4 Aug 2017 (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.
The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Placebo - deflated balloon | Sham comparator | Device: VIPUN Balloon Catheter 0.1 deflated, Drug: Placebo |
| Placebo - inflated balloon | Placebo comparator | Drug: Placebo, Device: VIPUN Balloon Catheter 0.1 inflated |
| Codeine - delfated balloon | Active comparator | Device: VIPUN Balloon Catheter 0.1 deflated, Drug: Codeine Phosphate |
| Codeine - inflated balloon | Active comparator | Drug: Codeine Phosphate, Device: VIPUN Balloon Catheter 0.1 inflated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent
- Aged between and including 18 and 65 years
- BMI between and including 18 and 25
- Understand and able to read Dutch
- In good health on the basis of medical history
Key exclusion criteria (22 listed)
- Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
- 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
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 Balloon Catheter 0.1 deflateddeflation balloon | Device | Codeine - delfated balloon, Placebo - deflated balloon |
| Codeine Phosphate58.8 mg codeïne phosphate | Drug | Codeine - delfated balloon, Codeine - inflated balloon |
| PlaceboSirupus Simplex | Drug | Placebo - deflated balloon, Placebo - inflated balloon |
| VIPUN Balloon Catheter 0.1 inflatedVIPUN Balloon Catheter 0.1 inflated | Device | Codeine - inflated balloon, Placebo - inflated balloon |
Primary outcome
Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.
Time frame: 8 hours
Incidence, frequency, severity, seriousness and relatedness of AEs
Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.
Time frame: 8 hours
Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)
Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.
Time frame: 8 hours
Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)
2 secondary outcomes
Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon
Time frame: 8 hours
Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)
Time frame: 8 hours
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 4 May 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.
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 Balloon Catheter 0.1 deflated, Codeine Phosphate and VIPUN Balloon Catheter 0.1 inflated in people with Healthy and Motility Disorder, 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 9 inclusion and 22 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 4 May 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. Some participants in this study may receive a placebo. 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?
Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit. (time frame: 8 hours). The study lists 3 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 4 May 2018.