Clinical Evaluation of the VIPUN Balloon Catheter 0.1 (ANTERO-1)
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ClinicalTrials.gov Identifier: NCT03239821 |
Recruitment Status :
Completed
First Posted : August 4, 2017
Last Update Posted : May 4, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Motility Disorder Gastric Emptying | Device: VIPUN Balloon Catheter 0.1 deflated Drug: Codeine Phosphate Drug: Placebo Device: VIPUN Balloon Catheter 0.1 inflated | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | A single-blinded, monocenter, randomized crossover investigation in healthy volunteers. |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility |
Actual Study Start Date : | September 25, 2017 |
Actual Primary Completion Date : | March 27, 2018 |
Actual Study Completion Date : | April 30, 2018 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Placebo - deflated balloon |
Device: VIPUN Balloon Catheter 0.1 deflated
deflation balloon Drug: Placebo Sirupus Simplex |
Placebo Comparator: Placebo - inflated balloon |
Drug: Placebo
Sirupus Simplex Device: VIPUN Balloon Catheter 0.1 inflated VIPUN Balloon Catheter 0.1 inflated |
Active Comparator: Codeine - delfated balloon |
Device: VIPUN Balloon Catheter 0.1 deflated
deflation balloon Drug: Codeine Phosphate 58.8 mg codeïne phosphate |
Active Comparator: Codeine - inflated balloon |
Drug: Codeine Phosphate
58.8 mg codeïne phosphate Device: VIPUN Balloon Catheter 0.1 inflated VIPUN Balloon Catheter 0.1 inflated |
- 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)
- Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon [ Time Frame: 8 hours ]To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.
- Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon) [ Time Frame: 8 hours ]To explore whether there is a correlation between gastric motility and emptying.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
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
Exclusion criteria related to positioning of the catheter:
- 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
Exclusion criteria related to codeine administration:
- 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
Exclusion criteria related to nutrients (Fortimel):
• Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239821
Belgium | |
UZ Leuven Gasthuisberg | |
Leuven, Belgium, 3000 |
Responsible Party: | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT03239821 |
Other Study ID Numbers: |
S60320 |
First Posted: | August 4, 2017 Key Record Dates |
Last Update Posted: | May 4, 2018 |
Last Verified: | July 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Codeine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |