← Trials/Trial dossier/NCT06927401

Not yet recruitingPhase NA

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

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

NCT IDNCT06927401
Org study IDETX-IND-01

Timeline

Milestones

Study start2025-04-08estimated
Study first posted2025-04-15actual
Last update posted2025-04-15actual
Primary completion2025-06-30estimated
Study completion2025-08-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersPerioperative / gastric aspiration risk

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

Other clinical outcomes
6
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other (unclassified)
1

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Patient Tolerance Score for Flower Capsule

Time frame:Immediately after Flower capsule examination

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse 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 endpoints
Primary/protocol endpoint

Detection of Retained Gastric Contents Using Flower Capsule

Time frame:Within 1 hour post-capsule ingestion

threshold achievement, descriptive

Secondary/protocol endpoint

Visualization of Gastric Anatomical Landmarks

Time frame:Within 1 hour post-capsule ingestion

descriptive

Secondary/protocol endpoint

Gastric Mucosal Visualization Score

Time frame:Within 1 hour post-capsule ingestion

descriptive

Secondary/protocol endpoint

Gastric Cleanliness Score

Time frame:Within 1 hour post-capsule ingestion

descriptive

Secondary/protocol endpoint

Time to Complete Gastric Examination

Time frame:Within 1 hour post-capsule ingestion

descriptive

Secondary/protocol endpoint

Capsule Swallowing Success

Time frame:Within 15 minutes of capsule administration

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Total 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.