An interventional study of VIPUN GMS and Erythromycin Lactobionate in Gastric Motility, sponsored by Prof Dr Jan Tack. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Prof Dr Jan Tack · Not applicable, Interventional, and Basic science
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.
Prof Dr Jan Tack is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study.
Device: VIPUN GMS · Drug: Erythromycin Lactobionate
Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).
Test model: Erythromycin has gastroprokinetic properties. 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. Erythromycin Lactobionate infusion: 200 mg i.v. infusion over a period of 20 minutes. Note: Erythromycin is not labeled as a gastroprokinetic agent in Belgium.
GBMI baseline
Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1.
Time frame: t = 0 - 119 minutes
GBMI120 - 139
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.
Time frame: t = 120 - 139 minutes
GBMI140-240
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.
Time frame: t = 140 - 240 minutes
Symptoms
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.
Time frame: t = 0 - 240 minutes
Incidence of adverse events
Incidence of adverse events
Time frame: t = 0 - 240 minutes
Severity of adverse (device) events/effects
Severity of adverse (device) events/effects
Time frame: t = 0 - 240 minutes
Seriousness of adverse (device) events/effects
Seriousness of adverse (device) events/effects
Time frame: t = 0 - 240 minutes
Relatedness of adverse (device) events/effects
Relatedness of adverse (device) events/effects
Time frame: t = 0 - 240 minutes
Incidence of device deficiencies of the investigational medical device
Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
Time frame: t = 0 - 240 minutes
Incidence of protocol deviations related to the investigational medical device
Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
Time frame: t = 0 - 240 minutes
Plan to share: No
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Prof Dr Jan Tack