Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System

Conditions
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Gastric Motor Function

Intervention / Treatment
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* Device: VIPUN Gastric Monitoring System prototype


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Aged between and including 18 and 65 years In good health on the basis of medical history and anamnesis by the Principal Investigator (or delegate) Agrees to refrain from drug, non-allowed medication, herbal supplement and dietary supplement intake on the day of the study visit Agrees to an overnight fast in advance of the study visit Exclusion Criteria: Current or chronic gastrointestinal symptoms Use of any medication that might affect gastric function or visceral sensitivity in the opinion of the PI (Suspected) current use of illicit drugs Psychiatric or neurological illness Any history of gastrointestinal surgery that could influence normal gastric function in the opinion of the PI, including, but not limited to gastrectomy, esophagectomy, duodenotomy, pancreatectomy, bariatric surgery (bypass surgery, gastric banding…), placement of neuromodulator Simultaneous participation in other clinical studies Suspected or confirmed basal skull fracture, mid face trauma or maxillofacial trauma Nasopharyngeal surgery in the last 30 days History of severe coagulation abnormalities Therapeutic or prophylactic anticoagulation Gastrointestinal bleeding Ischemic bowel Peritonitis Deviated nasal septum impeding catheter placement Inability to pass a feeding tube through the nares (e.g. in case of anatomical features, nasal congestion or blockage) Recent (< 30 days) caustic ingestion (due to risk of esophageal rupture) Recent (< 30 days) esophageal varices (active, untreated or recently banded/cauterized) History of esophageal strictures History of gastric varices History of gastric obstruction History of gastrectomy, esophagectomy, duodeno-pancreatectomy, bypass surgery, gastric banding, bariatric balloon, or short bowel syndrome History of gastrostomy Allergy to components of the VIPUN Catheter Pregnancy or breastfeeding Allergy to components of the enteral nutrition Allergy to the available lubricants Allergy to the available local anesthetic Recent infection with SARS-CoV-2 (in the last 2 weeks prior to study visit).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: VIPUN Gastric Monitoring System prototype<br>* 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.<br>* Other names: VIPUN GMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical device investigation