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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time of gastric contractions identified by means of the investigational medical device
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •At least 18 years old
- •BMI between and including 18 and 30
- •Understand and able to read Dutch
- •In good health on the basis of medical history
排除标准
- •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
研究组 & 干预措施
Combined pressure measurement and MRI
Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI.
干预措施: VIPUN Gastric Monitoring System prototype (Device)
结局指标
主要结局
Time of gastric contractions identified by means of the investigational medical device
时间窗: 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
时间窗: 30 minutes
The exact time at which each gastric contractile event is most clearly visible within a 30-minute recording period is documented.
次要结局
未报告次要终点