Status:
NOT_YET_RECRUITING
Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users
Lead Sponsor:
Asian Institute of Gastroenterology, India
Collaborating Sponsors:
Endiatx
Conditions:
Endoscopy, Digestive System
GLP1-R-related Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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 1.5...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06927401
Start Date
April 8 2025
End Date
August 30 2025
Last Update
April 15 2025
Active Locations (1)
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1
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, India, 500082