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

NCT05264363 | Completed

• 1 other identifier: LOTUS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• VIPUN GMS contraction frequency

  protocol time T=0-120 minutes

• Manometry contraction frequency

  protocol time T=0-120 minutes

• Motility Tiled Runner contraction frequency

  protocol time T=0-120 minutes

• Hallmarks of normal motility

  protocol time T=0-150 minutes

• Duration of MMC phases

  protocol time T=0-150 minutes

Other Outcomes (2)

• 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).

• Device safety

  Throughout study visit (from the moment the investigational medical device is applied until it is removed).

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

VIPUN Gastric Monitoring System prototype 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.

Also known as: VIPUN GMS

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VIPUN Medical: lead

Study Sites (1)

Translational Research Center for Gastrointestinal Disorders - KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Jan Tack, PhD, MD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 3, 2022
• Study Start: February 10, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)