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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
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
36
estimated
Study population
Healthy volunteers, Perioperative / gastric aspiration risk
Key I/E criterion
—
Primary endpoint
•Detection of Retained Gastric Contents
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Patient-reported / QoL
1 endpointPatient Tolerance Score for Flower Capsule
Time frame:Immediately after Flower capsule examination
descriptive
Safety / tolerability / PK
1 endpointAdverse Events Related to Flower Capsule
Time frame:From Day 0 to Day 14
Treatment-emergent AEs (any)
event count, event
componentsNausea
Other clinical outcomes
6 endpointsDetection of Retained Gastric Contents Using Flower Capsule
Time frame:Within 1 hour post-capsule ingestion
threshold achievement, descriptive
Visualization of Gastric Anatomical Landmarks
Time frame:Within 1 hour post-capsule ingestion
descriptive
Gastric Mucosal Visualization Score
Time frame:Within 1 hour post-capsule ingestion
descriptive
Gastric Cleanliness Score
Time frame:Within 1 hour post-capsule ingestion
descriptive
Time to Complete Gastric Examination
Time frame:Within 1 hour post-capsule ingestion
descriptive
Capsule Swallowing Success
Time frame:Within 15 minutes of capsule administration
descriptive
Other (unclassified)
1 endpointTotal Water Volume Consumed
Time frame:Prior to capsule ingestion
descriptive
Publications (7)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Journal of clinical anesthesia2023 Aug (month)PMID36870274doi:10.1016/j.jclinane.2023.111091via CT.gov background
- Indian journal of anaesthesia2022 Apr (month)PMID35663207doi:10.4103/ija.ija_783_21via CT.gov background
- Indian journal of anaesthesia2018 Oct (month)PMID30443057doi:10.4103/ija.IJA_147_18via CT.gov background
- Journal of dental anesthesia and pain medicine2017 Mar (month)PMID28879323doi:10.17245/jdapm.2017.17.1.1via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.