ANTERO-6 Cine-MRI Study

NCT04847765 | Completed

• 1 other identifier: S65104
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health

Outcome Measures

Primary Outcomes (2)

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

  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.

  30 minutes

• Gastric contractions identified visually by an expert radiologist

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

  30 minutes

Study Arms (1)

Combined pressure measurement and MRI

EXPERIMENTAL

Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI.

Device: VIPUN Gastric Monitoring System prototype

Interventions

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.

Combined pressure measurement and MRI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: April 21, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

BE (1)