NCT04485936已完成不适用
Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects
Epitomee medical2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluation of Epitomee device on Gastric half-emptying time
研究概览
简要总结
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
详细描述
The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).
Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.
After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 ≤ Age <65 years
- •20 < BMI ≤ 40 kg/m2
- •Healthy subject
- •Subject is able and willing to give informed consent
- •Subject is able and willing to participate in the study and follow protocol procedures
排除标准
- •Significant swallowing disorders or difficulty swallowing
- •Suspected GI strictures, fistulas or other GI track obstructions
- •Crohn's disease or diverticulosis
- •Recent GI surgery
- •History of long-standing undigested food in the stomach
- •Known ulcer disease
- •Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder
- •Presence of a gastrostomy tube or gastric outlet obstruction
- •History or evidence of any active liver disease
- •Allergy to eggs
- •Treatment with anticholinergic or prokinetic agents
- •Treatment with proton-pump inhibitors
- •Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine)
- •Prediabetes or Diabetes
- •Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
- •Pregnancy or breastfeeding
- •Currently participating in an ongoing clinical study
结局指标
主要结局
Evaluation of Epitomee device on Gastric half-emptying time
时间窗: 10 days
Change in Gastric half-emptying time
次要结局
未报告次要终点
研究者
研究点 (2)
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