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In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure measurement similar to high-resolution manometry (HRM).
In addition, the study aims to contribute to the design and development of a position confirmation functionality integrated in the VIPUN Gastric Monitoring System by establishing volume-pressure relations in the stomach and esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The main intervention is the application of the Investigational Medical Device (VIPUN Gastric Monitoring System prototype) together with the reference device (solid state high-resolution manometry) to record intraluminal pressure. The planned procedures are identical for all subjects in this single-arm investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPUN Gastric Monitoring System prototype | Device | The Investigational Medical Device (IMD) is used simultaneously with the reference device (solid state high-resolution manometry) to record gastric intraluminal pressure for approximately 2.5 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of gastric contractility on VIPUN GMS | Time the smoothed and baseline-corrected VIPUN GMS pressure exceeds the contraction-threshold. | protocol time T=0-120 minutes |
| Duration of gastric contractility on manometry | Time the smoothed and baseline-corrected gastric manometry pressure exceeds the contraction-threshold | protocol time T=0-120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| VIPUN GMS contraction frequency | Gastric contractions identified visually by a expert gastroenterologists on the VIPUN GMS recording. | protocol time T=0-120 minutes |
| Manometry contraction frequency |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity | The severity of epigastric and nasopharyngeal symptoms are surveyed by means of a questionnaire throughout the study visit. | Throughout the study visit, specifically at baseline, during stepwise inflation (at each volume increment), and during the motility recording (at protocol time T=0, 60, 120 and 150 minutes). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, PhD, MD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Center for Gastrointestinal Disorders - KU Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2024 | |
| Reset | Sep 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2024 | Sep 16, 2024 |
A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.
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Gastric contractions identified visually by a expert gastroenterologists on the manometry recording.
| protocol time T=0-120 minutes |
| Motility Tiled Runner contraction frequency | Motility Tile Runner contractions are gastric contractions identified by the VIPUN Motility Tiled Runner software application. | protocol time T=0-120 minutes |
| Hallmarks of normal motility | The presence/absence of hallmarks of normal gastric motility are scored by expert gastroenterologists on the VIPUN GMS pressure recording and on the manometry recording independently. | protocol time T=0-150 minutes |
| Duration of MMC phases | The duration of MMC phase III is delineated by expert gastroenterologists on the VIPUN GMS pressure recording and on the manometry recording independently. | protocol time T=0-150 minutes |
| Nutrient-induced changes in tonic contractility | Defined as the difference between baseline GMS pressure before and during nutrient administration. | protocol time T=0-150 minutes |
| Nutrient-induced changes in phasic contractility | Defined as the difference between the frequency of Motility Tiled Runner contractions before and during nutrient administration. | protocol time T=0-150 minutes |
| Volume-pressure relation during stepwise inflation | The pressure at each volume increment (range 0-135 ml) is recorded during stepwise inflation of the VIPUN GMS Catheter in the esophagus and in the stomach. | Prior to protocol time T=0 minutes (=start motility recording). |
| Device safety |
All adverse events and device deficiencies are recorded. |
| Throughout study visit (from the moment the investigational medical device is applied until it is removed). |