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

NCT ID: NCT05264363

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-12-12

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.

Conditions

Gastric Motor Function

Keywords

Medical device investigation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VIPUN Gastric Monitoring System prototype

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

VIPUN GMS

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VIPUN Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Translational Research Center for Gastrointestinal Disorders - KU Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

LOTUS

Identifier Type: -

Identifier Source: org_study_id