Clinical trial NCT05264363: Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
Official title: Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Motor Function
Keywords: Medical device investigation
Lead sponsor: VIPUN Medical
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Duration of gastric contractility on VIPUN GMS
timeFrame: protocol time T=0-120 minutes
measure: Duration of gastric contractility on manometry
timeFrame: protocol time T=0-120 minutes
Secondary outcomes:
measure: VIPUN GMS contraction frequency
timeFrame: protocol time T=0-120 minutes
measure: Manometry contraction frequency
timeFrame: protocol time T=0-120 minutes
measure: Motility Tiled Runner contraction frequency
timeFrame: protocol time T=0-120 minutes
measure: Hallmarks of normal motility
timeFrame: protocol time T=0-150 minutes
measure: Duration of MMC phases
timeFrame: protocol time T=0-150 minutes
measure: Nutrient-induced changes in tonic contractility
timeFrame: protocol time T=0-150 minutes
measure: Nutrient-induced changes in phasic contractility
timeFrame: protocol time T=0-150 minutes
measure: Volume-pressure relation during stepwise inflation
timeFrame: Prior to protocol time T=0 minutes (=start motility recording).
Other outcomes:
measure: Symptom severity
timeFrame: 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).
measure: Device safety
timeFrame: Throughout study visit (from the moment the investigational medical device is applied until it is removed).
Locations:
city: Leuven
country: Belgium
facility: Translational Research Center for Gastrointestinal Disorders - KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Jan Tack, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: