ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model
- Conditions
- Gastric Motility
- Interventions
- Device: VIPUN GMS
- Registration Number
- NCT04066231
- Lead Sponsor
- Prof Dr Jan Tack
- Brief Summary
It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults (S60320 / AFMPS80M0687).
Erythromycin is a gastroprokinetic agent, known to stimulate gastric contractility. A single dose of 200 mg erythromycin has been shown to induce a prolonged period of enhanced phasic contractile activity.
The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults.
The performance of the VIPUN GMS can be enhanced by data-driven optimization of the VIPUN Motility Algorithm, used to quantify gastric motility.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Signed Informed Consent
- Aged between and including 18 and 65 years
- BMI between and including 18 and 30
- Understand and able to read Dutch
- In good health on the basis of medical history
- Refrains from herbal, vitamin and other dietary supplements on the day of the visits
- 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
- History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- Nasopharyngeal 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
- Pregnant or breastfeeding women
- Have known side-effects/allergic reactions when taking erythromycin or other macrolide antibiotics (such as azithromycin, clarithromycin)
- Kidney disease
- Liver disease
- Myasthenia gravis
- QT prolongation (QT ≥400 ms) at the screening
- Cardiac arrhythmia or heart failure
- History of C. difficile infection
- Family history of QT prolongation, sudden cardiac death or other heart problems
- Recent vaccinations with live bacterial vaccines (such as typhoid vaccine)
- Concomitant medication use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VIPUN GMS VIPUN GMS Single arm study. VIPUN GMS Erythromycin Lactobionate Single arm study.
- Primary Outcome Measures
Name Time Method GBMI baseline t = 0 - 119 minutes Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
GBMI120 - 139 t = 120 - 139 minutes Motility during erythromycin administration. Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
- Secondary Outcome Measures
Name Time Method Seriousness of adverse (device) events/effects t = 0 - 240 minutes Seriousness of adverse (device) events/effects
GBMI140-240 t = 140 - 240 minutes Motility in the period 140 - 240 minutes. Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
Relatedness of adverse (device) events/effects t = 0 - 240 minutes Relatedness of adverse (device) events/effects
Incidence of protocol deviations related to the investigational medical device t = 0 - 240 minutes Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
Symptoms t = 0 - 240 minutes Epigastric symptoms (nausea, bloating, pain) are surveyed with Visual Analogue Scales for severity of each individual symptom (100 mm, 0 = Absent to 100 mm = worst possible sensation) at a 15 minute interval.
Incidence of adverse events t = 0 - 240 minutes Incidence of adverse events
Severity of adverse (device) events/effects t = 0 - 240 minutes Severity of adverse (device) events/effects
Incidence of device deficiencies of the investigational medical device t = 0 - 240 minutes Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium