ANTERO-6 Cine-MRI Study

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT04847765

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health	Device: VIPUN Gastric Monitoring System prototype	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official 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

Actual Study Start Date :

Apr 21, 2021

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined pressure measurement and MRI Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI.	Device: VIPUN Gastric Monitoring System prototype 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.

Arm

Intervention/Treatment

Experimental: Combined pressure measurement and MRI

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

Device: VIPUN Gastric Monitoring System prototype

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.

Outcome Measures

Primary Outcome Measures

Time of gastric contractions identified by means of the investigational medical device [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 [30 minutes]
The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT04847765

Other Study ID Numbers:

S65104

First Posted:

Apr 19, 2021

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 30, 2021