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

Condition(s) studied

Investigational drug(s) / intervention(s)

Flower: Flower is a single-use capsule endoscope designed for timely visualization of the human stomach. The patient drinks water to fill the stomach before swallowing the Flower capsule, which transmits wireless video, through an external dongle placed near the patient's abdomen, to a physician's computer or smartphone. Flower is weighted to orientationally bias the capsule upward, meaning that with a few simple position adjustments a complete viewing of the stomach can be achieved approximately 10 minutes. The procedure requires no sedation or equipment other than the Flower System (capsule and dongle). As a simple means of screening, Flower functions equivalent to comparable technologies, but offers advantages of being less invasive and burdensome. Flower has fewer potentially adverse consequences than traditional endoscopy (EGD), and it does not require capital equipment as magnetic endoscopy does. Flower offers the identification and location of bleeding sources in the stomach.

Study summary

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.

2\. 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

Eligibility

Primary outcome measure(s)

• Detection of Retained Gastric Contents Using Flower Capsule — 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).

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India