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

Launched by ASIAN INSTITUTE OF GASTROENTEROLOGY, INDIA · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new device called the Flower capsule, which is used to check for retained gastric contents (RGC) in the stomach. Essentially, the study aims to determine how well this capsule can identify if there is leftover food or liquid in the stomach after eating. The researchers will compare the results from the Flower capsule to a standard procedure called esophagogastroduodenoscopy (EGD), which involves using a camera to look inside the stomach. The study will include healthy adults aged 18 to 65 who are willing to participate and meet certain health criteria, such as not having a history of gastrointestinal disorders or swallowing problems.

Participants in this study can expect to swallow the Flower capsule and undergo an examination of their stomach to assess how well the capsule works. They will also be monitored for any side effects, like nausea or discomfort, and how much water they can drink while taking the capsule. It’s important to note that individuals who have used GLP-1 receptor agonists (a type of medication for diabetes) in the last three months or have certain health conditions will not be eligible to join the trial. This study is still in the planning stages and has not yet started recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years and \< 65 years (male or female)
• • 2. Willing and able to sign an IEC-approved informed consent form
• • 3. Willing and able to comply with all study requirements
• Exclusion Criteria:
• • 1. History of gastrointestinal disorders
• • 2. History of gastroparesis
• • 3. History of prior gastric surgery
• • 4. Swallowing disorders
• • 5. Contraindications to EGD or capsule endoscopy
• • 6. Use of GLP-1 receptor agonists in the last 3 months
• • 7. Diagnosed with diabetes mellitus
• • 8. Classified as obese (based on BMI criteria)
• • 9. Pregnant or lactating