ANTERO-6 Cine-MRI Study

Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions.

However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.

Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.

To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.

The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.

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Key information

Conditions

Health

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed Informed Consent
At least 18 years old
Male
BMI between and including 18 and 30
Understand and able to read Dutch
In good health on the basis of medical history

Exclusion criteria

Using any medication that might affect gastric function or visceral sensitivity
Known / suspected current use of illicit drugs
Known psychiatric or neurological illness
Any gastrointestinal surgery that could influence normal gastric function in the opinion of the Investigator
History of heart or vascular diseases like irregular heartbeats, angina or heart attack
Nasopharyngeal surgery in the last 30 days
History of thermal or chemical injury to upper respiratory tract or esophagus
Current esophageal or nasopharyngeal obstruction
Known coagulopathy
Known esophageal varices
Metal or other MRI incompatible implants
Contra-indications for MR (checked by MR safety questionnaire)
Claustrophobia

Treatment and study plan

VIPUN Gastric Monitoring System prototype

Device

The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile.

The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging.

Primary outcomes

Time of gastric contractions identified by means of the investigational medical device

Time frame: 30 minutes

Analysis software filters the pressure signal and identifies individual gastric contractions.

The exact time at which each contraction is detected within a 30-minute recording period is documented.
Gastric contractions identified visually by an expert radiologist

Time frame: 30 minutes

The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

A Pilot Study to Assess the Procedural Feasibility to Combine and Compare Dynamic Magnetic Resonance Imaging and an Isovolumetric Intragastric Balloon to Assess Gastric Contractility in Healthy Adults

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 19, 2021
Registry last updated: Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed