Confirming Flower capsule performance characteristics in detection of retained gastric contents

Not yet recruiting

• Conditions: No history of gastrointestinal disorders, gastroparesis, or prior gastric surgery.

• Registration Number: CTRI/2025/04/084367
• Lead Sponsor: Endiatx

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-18
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Individuals willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the detection of retained gastric contents and assess safety using the Flower Capsule Endoscopy in healthy	2 Months
individuals and GLP-1 receptor agonist users outcome measures will be documented, including the visualization of retained gastric contents; identification of	2 Months
capsule aspiration, nausea, or pain.	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	2 Months

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

Asian Institute of Gastroenterology Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Asian Institute of Gastroenterology Hospital

🇮🇳Hyderabad, TELANGANA, India

Dr Rakesh Kalapala

Principal investigator

drrakeshkalapala@aighospitals.com