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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Motor Function
• Intervention / Treatment: Device: VIPUN Gastric Monitoring System prototype

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Translational Research Center for Gastrointestinal Disorders - KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.; Other Names: VIPUN GMS

What is the study measuring?

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).

Other Outcome Measures

Outcome Measure	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).
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).

Collaborators and Investigators

• Sponsor: VIPUN Medical
• Investigators: Principal Investigator: Jan Tack, PhD, MD, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Medical device investigation
• Other Study ID Numbers: LOTUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No