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
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
History of gastrointestinal disorders
History of gastroparesis
History of prior gastric surgery
Swallowing disorders
Crossover
Flower
DeviceFlower 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.
Detection of Retained Gastric Contents Using Flower Capsule
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).
Visualization of Gastric Anatomical Landmarks
Number of gastric landmarks (fundus, cardia, lesser curvature, greater curvature, angulus, antrum, pylorus) successfully visualized using the Flower capsule.
Gastric Mucosal Visualization Score
Quality of mucosal visualization at each landmark based on a 4-point scale (1 = Poor, 4 = Excellent).
Gastric Cleanliness Score
Degree of gastric cleanliness based on a 4-point scale (1 = Poor, 4 = Excellent).
Adverse Events Related to Flower Capsule
Number of participants with any of the following adverse events: capsule retention, aspiration, nausea, pain, perforation.
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Asian Institute of Gastroenterology, India
Lead sponsor
Endiatx
Collaborator
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