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Investigational medical device no longer available
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIPUN GMS | Experimental | Single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPUN GMS | Device | Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS). |
|
| Measure | Description | Time Frame |
|---|---|---|
| GBMI baseline | Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1. | 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. | t = 120 - 139 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | t = 140 - 240 minutes |
| Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33025716 | Derived | Goelen N, Tack J, Janssen P. Erythromycin stimulates phasic gastric contractility as assessed with an isovolumetric intragastric balloon pressure measurement. Neurogastroenterol Motil. 2021 Feb;33(2):e13991. doi: 10.1111/nmo.13991. Epub 2020 Oct 6. |
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| ID | Term |
|---|---|
| C010948 | erythromycin lactobionate |
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A gastroprokinetic agent is administered to stimulate gastric motility.
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| Erythromycin Lactobionate | Drug | 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. |
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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.
| t = 0 - 240 minutes |
| Incidence of adverse events | Incidence of adverse events | t = 0 - 240 minutes |
| Severity of adverse (device) events/effects | Severity of adverse (device) events/effects | t = 0 - 240 minutes |
| Seriousness of adverse (device) events/effects | Seriousness of adverse (device) events/effects | t = 0 - 240 minutes |
| Relatedness of adverse (device) events/effects | Relatedness of adverse (device) events/effects | 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 | 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 | t = 0 - 240 minutes |