None listed
Conditions
Interventions
Intervention1: Flower: A controlled, prospective, between-participants study design to assess Flower in detecting the presence or absence of retained gastric contents (RGC), using sedated esophagogast
Sponsors
Endiatx
Eligibility
Inclusion criteria
Inclusion criteria: Individuals willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the detection of retained gastric contents and assess safety using the Flower Capsule Endoscopy in healthy individuals and GLP-1 receptor agonist users outcome measures will be documented, including the visualization of retained gastric contents; identification of 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 capsule aspiration, nausea, or pain.Timepoint: 2 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactRakesh Kalapala
Asian Institute of Gastroenterology Hospital
Outcome results
None listed