Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users
- Conditions
- Endoscopy, Digestive SystemGLP1-R-related Disease
- Registration Number
- NCT06927401
- Lead Sponsor
- Asian Institute of Gastroenterology, India
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Detection of Retained Gastric Contents Using Flower Capsule Within 1 hour post-capsule ingestion Proportion of participants in whom the presence or absence of retained gastric contents (\>1.5 mL/kg) is accurately identified using the Flower Capsule, compared to the reference standard (sedated EGD or known ingested volume).
- Secondary Outcome Measures
Name Time Method Visualization of Gastric Anatomical Landmarks Within 1 hour post-capsule ingestion Number of gastric landmarks (fundus, cardia, lesser curvature, greater curvature, angulus, antrum, pylorus) successfully visualized using the Flower capsule.
Gastric Mucosal Visualization Score Within 1 hour post-capsule ingestion Quality of mucosal visualization at each landmark based on a 4-point scale (1 = Poor, 4 = Excellent).
Gastric Cleanliness Score Within 1 hour post-capsule ingestion Degree of gastric cleanliness based on a 4-point scale (1 = Poor, 4 = Excellent).
Adverse Events Related to Flower Capsule From Day 0 to Day 14 Number of participants with any of the following adverse events: capsule retention, aspiration, nausea, pain, perforation.
Time to Complete Gastric Examination Within 1 hour post-capsule ingestion Total time required to complete Flower capsule-based gastric examination.
Capsule Swallowing Success Within 15 minutes of capsule administration Number of attempts required to successfully swallow the Flower capsule.
Total Water Volume Consumed Prior to capsule ingestion Total volume of water consumed to achieve adequate gastric distention prior to Flower examination.
Patient Tolerance Score for Flower Capsule Immediately after Flower capsule examination Participant-reported tolerance using a 10-point scale (1 = best experience, 10 = worst experience).
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Asian Institute of Gastroenterology Hospital
🇮🇳Hyderabad, Telangana, India
Asian Institute of Gastroenterology Hospital🇮🇳Hyderabad, Telangana, IndiaRakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNBContactNitin Jagtap Senior Consultant Gastroenterologist, MBBS, MD, DNBContactHardik Rughwani Senior Consultant Gastroenterologist, MBBS, MD, DNBContact