Gastric Motor Function
Conditions
Keywords
Medical device investigation
Brief summary
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.
Interventions
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.
Sponsors
VIPUN Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of gastric contractility on VIPUN GMS | protocol time T=0-120 minutes | Time the smoothed and baseline-corrected VIPUN GMS pressure exceeds the contraction-threshold. |
| Duration of gastric contractility on manometry | protocol time T=0-120 minutes | Time the smoothed and baseline-corrected gastric manometry pressure exceeds the contraction-threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VIPUN GMS contraction frequency | protocol time T=0-120 minutes | Gastric contractions identified visually by a expert gastroenterologists on the VIPUN GMS recording. |
| Manometry contraction frequency | protocol time T=0-120 minutes | Gastric contractions identified visually by a expert gastroenterologists on the manometry recording. |
| Hallmarks of normal motility | protocol time T=0-150 minutes | 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. |
| Nutrient-induced changes in tonic contractility | protocol time T=0-150 minutes | Defined as the difference between baseline GMS pressure before and during nutrient administration. |
| Nutrient-induced changes in phasic contractility | protocol time T=0-150 minutes | Defined as the difference between the frequency of Motility Tiled Runner contractions before and during nutrient administration. |
| Volume-pressure relation during stepwise inflation | Prior to protocol time T=0 minutes (=start motility recording). | 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. |
| Duration of MMC phases | protocol time T=0-150 minutes | The duration of MMC phase III is delineated by expert gastroenterologists on the VIPUN GMS pressure recording and on the manometry recording independently. |
| Motility Tiled Runner contraction frequency | protocol time T=0-120 minutes | Motility Tile Runner contractions are gastric contractions identified by the VIPUN Motility Tiled Runner software application. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity | 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). | The severity of epigastric and nasopharyngeal symptoms are surveyed by means of a questionnaire throughout the study visit. |
| Device safety | Throughout study visit (from the moment the investigational medical device is applied until it is removed). | All adverse events and device deficiencies are recorded. |
Countries
Belgium
Outcome results
None listed