Clinical trial NCT06927401: Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users
Official title: Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endoscopy, Digestive System
GLP1-R-related Disease
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
Collaborators: name: Endiatx
First posted: 2025-04-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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 1.5mL/kg in Healthy volunteers

1. Study Purpose

a. A controlled, prospective, between-participants study design to assess Flower in detecting the presence or absence of retained gastric contents (RGC), using sedated esophagogastroduodenoscopy (EGD) as the ground truth for an empty stomach and known ingested volume as the ground truth for a fed participant.

2. Study Endpoints

a. Primary i. Visualization of Retained Gastric Contents b. Secondary i. Gastric mucosal visualization of the seven anatomical landmarks of the stomach (fundus, cardia, lesser gastric curvature, greater gastric curvature, angulus, antrum, and pylorus) ii. Gastric Cleanliness iii. Adverse events defined as capsule retention, capsule aspiration, perforation, nausea, and pain iv. Maximum, tolerated water consumed v. Patient tolerance vi. Exploratory attempts for successful swallowing vii. Exploratory minimum and maximum water volume for optimal Flower performance viii. Time required for gastric examination completion by Flower

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, and those taking GLP-1 receptor agonists. The preoperative identification of retained gastric contents (RGC) is crucial in guiding anesthetic management, including the decision to perform endotracheal intubation, and in reducing the risk of aspiration-related complications.

The Flower System is a novel, single-use, wireless capsule endoscopy platform developed to provide real-time gastric imaging at the bedside without the need for sedation or advanced endoscopic infrastructure. The system consists of three key components: (1) the ingestible Flower capsule with an integrated high-resolution camera and software for orientational bias; (2) a wireless Dongle that receives and transmits video data to the physician's computer or smartphone; and (3) a software application with a user interface for image visualization, storage, and interpretation.

This clinical feasibility study evaluates the diagnostic performance and safety of the Flower capsule in two populations: (1) healthy volunteers (Study I), and (2) patients receiving GLP-1 receptor agonists (Study II; not described here). This protocol pertains to Study I only.

Study Design Overview - Study I This is a prospective, controlled, between-participant study comparing the diagnostic capability of the Flower capsule with sedated esophagogastroduodenoscopy (EGD), which serves as the ground truth standard for the presence or absence of gastric contents.

Twenty-four (n=24) healthy volunteers will be randomly assigned to one of two arms:

Group 1 - Empty Stomach Validation: Participants fast for 8 hours from solids and 2 hours from liquids, undergo sedated EGD to confirm an empty stomach, and then undergo Flower capsule evaluation.

Group 2 - Gastric Content Detection: Participants fast identically, undergo EGD to confirm an empty stomach, consume 1.5 mL/kg of a standardized semi-solid meal (post-alertness), and subsequently undergo Flower capsule evaluation.

A gastroenterologist blinded to fasting/fed status will assess the Flower capsule images for RGC and other endpoints.

Study Objectives Primary Objective: To determine the sensitivity and specificity of the Flower capsule in detecting RGC (\>1.5 mL/kg) compared to the known ingested volume (fed group) and EGD (fasted group).

Secondary Objectives: To evaluate visualization of gastric landmarks, gastric cleanliness, safety (adverse events including capsule retention, aspiration, nausea, pain), water tolerance, examination duration, and patient-reported tolerance compared to EGD.

Technical Protocol All participants receive a structured hydration protocol using simethicone to minimize bubbles and improve mucosal visualization. Body position adjustments (supine, right lateral, left lateral, and prone) are used to achieve panoramic gastric visualization. The Flower capsule is orientationally biased to face upward, facilitating gravity-assisted mucosal inspection.

Participants are monitored for adverse events including capsule retention, aspiration, or signs of obstruction. Capsule passage is confirmed by participant-reported expulsion (with photographic evidence incentivized) and mandatory X-ray follow-up at 2 weeks post-procedure. In cases of non-expulsion, endoscopic or surgical retrieval will be arranged.

Evaluation Metrics Retained Gastric Contents: Binary detection (present/absent) based on image review.

Gastric Landmarks Visualized: Seven regions (fundus, cardia, lesser and greater curvatures, angulus, antrum, pylorus).

Mucosal Visualization Quality (4-point scale):

Grade 1: \<50% Grade 2: ≥50% Grade 3: ≥75% Grade 4: ≥90%

Gastric Cleanliness Score (4-point scale):

Grade 1: Large debris/turbidity, no visualization Grade 2: Significant interference Grade 3: Minor interference Grade 4: Clear view Patient Tolerance Score (1-10): Lower scores indicate better experience. Adverse Events: Documented from Day 0 to follow-up (Day 14). Capsule Swallow Attempts and Total Exam Time: Tracked as feasibility markers. Follow-Up and Safety Monitoring

Participants are discharged same-day if stable. Safety surveillance includes:

Night-of follow-up call Daily calls from Day 1 to Day 7 for symptom checks Mandatory Day 14 follow-up with physical exam, vital signs, adverse event reporting, and abdominal X-ray Lost-to-follow-up is defined after three failed phone contact attempts and one certified letter to the last known address. All study-related procedures and follow-up visits are provided at no cost to participants.

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

Primary outcomes:
measure: Detection of Retained Gastric Contents Using Flower Capsule
timeFrame: Within 1 hour post-capsule ingestion
Secondary outcomes:
measure: Visualization of Gastric Anatomical Landmarks
timeFrame: Within 1 hour post-capsule ingestion
measure: Gastric Mucosal Visualization Score
timeFrame: Within 1 hour post-capsule ingestion
measure: Gastric Cleanliness Score
timeFrame: Within 1 hour post-capsule ingestion
measure: Adverse Events Related to Flower Capsule
timeFrame: From Day 0 to Day 14
measure: Time to Complete Gastric Examination
timeFrame: Within 1 hour post-capsule ingestion
measure: Capsule Swallowing Success
timeFrame: Within 15 minutes of capsule administration
measure: Total Water Volume Consumed
timeFrame: Prior to capsule ingestion
measure: Patient Tolerance Score for Flower Capsule
timeFrame: Immediately after Flower capsule examination
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology Hospital
state: Telangana
Study officials:
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