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Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions.
However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.
Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.
To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.
The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined pressure measurement and MRI | Experimental | Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPUN Gastric Monitoring System prototype | Device | The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile. The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of gastric contractions identified by means of the investigational medical device | Analysis software filters the pressure signal and identifies individual gastric contractions. The exact time at which each contraction is detected within a 30-minute recording period is documented. | 30 minutes |
| Gastric contractions identified visually by an expert radiologist | The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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