Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 ReceptorAgonist Users
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluate the detection of retained gastric contents and assess safety using the Flower Capsule Endoscopy in healthy
研究概览
简要总结
Clinical Study Overview Feasibility Study Plan (Study 1: Healthy Participants) Study 1- Confirming Flower capsule performance characteristics in detection of retained gastric contents greater than 1.5mL/kg in Healthy volunteers
- Study Purpose
a. A controlled, prospective, between-participants study design to assess Flower in detecting the presence or absence of retained gastric contents (RGC), using sedated esophagogastroduodenoscopy (EGD) as the ground truth for an empty stomach and known ingested volume as the ground truth for a fed participant.
- Study Endpoints
a. Primary i. Visualization of Retained Gastric Contents b. Secondary i. Gastric mucosal visualization of the seven anatomical landmarks of the stomach (fundus, cardia, lesser gastric curvature, greater gastric curvature, angulus, antrum, and pylorus) ii. Gastric Cleanliness iii. Adverse events defined as capsule retention, capsule aspiration, perforation, nausea, and pain iv. Maximum, tolerated water consumed v. Patient tolerance vi. Exploratory attempts for successful swallowing vii. Exploratory minimum and maximum water volume for optimal Flower performance viii. Time required for gastric examination completion by Flower
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements.
排除标准
- •No history of : Gastrointestinal disorders, Gastroparesis, Prior gastric surgery, Swallowing disorders, Contraindications to EGD or capsule endoscopy and GLP-1 users in the last 3 months.
结局指标
主要结局
Evaluate the detection of retained gastric contents and assess safety using the Flower Capsule Endoscopy in healthy
时间窗: 2 Months
individuals and GLP-1 receptor agonist users outcome measures will be documented, including the visualization of retained gastric contents; identification of
时间窗: 2 Months
capsule aspiration, nausea, or pain.
时间窗: 2 Months
all seven gastric anatomical landmarks—fundus, cardia, lesser gastric curvature, lesser gastric curvature, greater gastric curvature, angulus, antrum, and pylorus; evaluation of gastric mucosal visualization; assessment of gastric cleanliness; evaluation of patient tolerance; total water volume intake; number of attempts required for successful capsule swallowing; time to complete the gastric examination; and documentation of any adverse events, such as
时间窗: 2 Months
次要结局
- NA(NA)