跳至主要内容
临床试验/NCT06927401
NCT06927401尚未招募不适用

Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年4月8日最近更新:
适应症
干预措施

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
Detection of Retained Gastric Contents Using Flower Capsule

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

  1. 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.

  1. 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

详细描述

There is an unmet clinical need for a rapid, accurate, and cost-effective tool to assess gastric content preoperatively, especially in high-risk populations such as individuals with obesity, diabetes, and those taking GLP-1 receptor agonists. The preoperative identification of retained gastric contents (RGC) is crucial in guiding anesthetic management, including the decision to perform endotracheal intubation, and in reducing the risk of aspiration-related complications.

The Flower System is a novel, single-use, wireless capsule endoscopy platform developed to provide real-time gastric imaging at the bedside without the need for sedation or advanced endoscopic infrastructure. The system consists of three key components: (1) the ingestible Flower capsule with an integrated high-resolution camera and software for orientational bias; (2) a wireless Dongle that receives and transmits video data to the physician's computer or smartphone; and (3) a software application with a user interface for image visualization, storage, and interpretation.

This clinical feasibility study evaluates the diagnostic performance and safety of the Flower capsule in two populations: (1) healthy volunteers (Study I), and (2) patients receiving GLP-1 receptor agonists (Study II; not described here). This protocol pertains to Study I only.

Study Design Overview - Study I This is a prospective, controlled, between-participant study comparing the diagnostic capability of the Flower capsule with sedated esophagogastroduodenoscopy (EGD), which serves as the ground truth standard for the presence or absence of gastric contents.

Twenty-four (n=24) healthy volunteers will be randomly assigned to one of two arms:

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
Single (Investigator)

盲法说明

The anesthesia team will be blinded to the Flower findings, and the EGD will proceed according to the standard clinical care to determine the appropriate anesthesia type and airway management approach. After 2 hours, a sedated EGD will be performed. A blinded gastroenterologist will review the images to determine the presence or absence of gastric content. Patient tolerance and Adverse Events will be documented. To minimize bias, the gastroenterologist interpreting the EGD images will be blinded to the finding of the Flower capsule.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age > 18 years and < 65 years (male or female)
  • •Willing and able to sign an IEC-approved informed consent form
  • •Willing and able to comply with all study requirements

排除标准

  • •History of gastrointestinal disorders
  • •History of gastroparesis
  • •History of prior gastric surgery
  • •Swallowing disorders
  • •Contraindications to EGD or capsule endoscopy
  • •Use of GLP-1 receptor agonists in the last 3 months
  • •Diagnosed with diabetes mellitus
  • •Classified as obese (based on BMI criteria)
  • •Pregnant or lactating

研究组 & 干预措施

Group 1-Fasting throughout Evaluation period

Experimental

In Group 1, participants will fast for 8 hours for food and 2 hours for clear fluids before undergoing a sedated EGD to confirm an empty stomach, serving as the ground truth. The procedure time, patient tolerance, presence or absence of gastric contents, and any adverse events (AEs) will be documented. After the fasting period and EGD, participants will consume 100 mL of water containing 400 mg of simethicone upon regaining full alertness. If necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will continue drinking until they feel full, with a typical intake ranging from 500 to 1400 mL of water. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. A blinded gastroenterologist, unaware of the participant's fasting

干预措施: Flower (Device)

Group 2- Fasting till 8 hours and fed during Evaluation period

Experimental

In Group 2, participants will follow the same fasting protocol as Group 1, with 8 hours of fasting for food and 2 hours for clear fluids, followed by a sedated EGD to confirm an empty stomach. The procedure time, patient tolerance, presence or absence of gastric contents, and AEs will be documented. After the fasting period and EGD, participants will consume 1.5 mL/kg of a standardized food mixture -representing the minimum volume associated with high aspiration risk-once participants have fully regained alertness. Participants will consume 100 mL of water with 400 mg of simethicone. As in Group 1, if necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which they will continue drinking until they feel full, with a typical intake ranging from 500 to 1000 mL of water.

干预措施: Flower (Device)

GLP 1 Participants

Experimental

Participants will continue taking their GLP-1 medication up to the day of the procedure. The participant will arrive at the hospital in the morning after following a 8 hour food fast and 2 hours for clear fluids. Following the fasting period, they will consume 100 mL of water containing 400 mg of simethicone. If necessary, participants should engage in light walking and avoid prolonged sitting. A 10-minute waiting period will then ensue, after which they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will be instructed to drink at least 500 mL of water, continuing until a sensation of fullness is reached, with a typical total intake ranging from 500 mL to 1400 mL. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. The Flower capsule will then be administered.

干预措施: Flower (Device)

结局指标

主要结局

Detection of Retained Gastric Contents Using Flower Capsule

时间窗: Within 1 hour post-capsule ingestion

Proportion of participants in whom the presence or absence of retained gastric contents (\>1.5 mL/kg) is accurately identified using the Flower Capsule, compared to the reference standard (sedated EGD or known ingested volume).

次要结局

  • Patient Tolerance Score for Flower Capsule(Immediately after Flower capsule examination)
  • Gastric Cleanliness Score(Within 1 hour post-capsule ingestion)
  • Adverse Events Related to Flower Capsule(From Day 0 to Day 14)
  • Time to Complete Gastric Examination(Within 1 hour post-capsule ingestion)
  • Capsule Swallowing Success(Within 15 minutes of capsule administration)
  • Total Water Volume Consumed(Prior to capsule ingestion)
  • Visualization of Gastric Anatomical Landmarks(Within 1 hour post-capsule ingestion)
  • Gastric Mucosal Visualization Score(Within 1 hour post-capsule ingestion)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (1)

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