ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Detection of distal stomach-induced contractions using various intragastric balloons
研究概览
简要总结
There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are between 18-60 years old.
- •Male and female.
- •Patients must provide witnessed written informed consent prior to any study procedures being performed.
排除标准
- •They are older than 60 years old and younger than 18 years.
- •They are taking medication.
- •Have severely decreased kidney function.
- •Have severely decreased liver function.
- •Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- •Have severe lung disease.
- •Have severe psychiatric illness or neurological illness.
- •Have any gastrointestinal disease.
- •Have any dyspeptic symptoms.
- •Women that are pregnant or breastfeeding.
研究组 & 干预措施
Circumference of 16 cm, cylinder form, length 11 cm
干预措施: Balloon characteristics (Device)
Circumference of 16 cm, cylinder form, length 18 cm
干预措施: Balloon characteristics (Device)
Circumference of 19 cm, sphere form (diameter of 6 cm)
干预措施: Balloon characteristics (Device)
Circumference of 19 cm, cylinder form, length 11 cm
干预措施: Balloon characteristics (Device)
Circumference of 22 cm, sphere form (diameter of 7 cm)
干预措施: Balloon characteristics (Device)
Circumference of 25 cm, sphere form (diameter of 8 cm)
干预措施: Balloon characteristics (Device)
Circumference of 28 cm, sphere form (diameter of 9 cm)
干预措施: Balloon characteristics (Device)
Circumference of 13 cm, sphere form (diameter of 4 cm)
干预措施: Balloon characteristics (Device)
Circumference of 13 cm, cylinder form, length 11 cm
干预措施: Balloon characteristics (Device)
Circumference of 16 cm, sphere form (diameter of 5 cm)
干预措施: Balloon characteristics (Device)
结局指标
主要结局
Detection of distal stomach-induced contractions using various intragastric balloons
时间窗: up to 1 year
A comparison of various intragastric balloons for the assessment of gastric motility
次要结局
未报告次要终点
研究者
Prof Dr Jan Tack
Prof. Dr.
Universitaire Ziekenhuizen KU Leuven