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

NCT05264363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-12-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • VIPUN Medical

    lead INDUSTRY

Principal Investigators

  • Jan Tack, PhD, MD · KU Leuven

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264363 on ClinicalTrials.gov