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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04847765
Other study ID # S65104
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date April 30, 2021

Study information

Verified date September 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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