Endoscopy, Digestive SystemNCT06927401
Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users
A study testing Flower in people with Endoscopy, Digestive System and GLP1-R-related Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Digestive System, GLP1-R-related Disease
- What is being tested?
- Flower
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 8 Apr 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Diagnosed with diabetes mellitus
- Classified as obese (based on BMI criteria)
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB contact
Nitin Jagtap Senior Consultant Gastroenterology, MBBS, MD, DNB contact
India1 site
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, 500082
Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB, 040 4244 4222, drrakeshkalapala@aighospitals.com
Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB
About this study
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
- Study Purpose
- 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.
- Study Endpoints
- 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
Read the 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.
- Being tested
- Flower
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowerDevice
Flower is a single-use capsule endoscope designed for timely visualization of the human stomach. The patient drinks water to fill the stomach before swallowing the Flower capsule, which transmits wireless video, through an external dongle placed near the patient's abdomen, to a physician's computer or smartphone. Flower is weighted to orientationally bias the capsule upward, meaning that with a few simple position adjustments a complete viewing of the stomach can be achieved approximately 10 minutes.
The procedure requires no sedation or equipment other than the Flower System (capsule and dongle). As a simple means of screening, Flower functions equivalent to comparable technologies, but offers advantages of being less invasive and burdensome. Flower has fewer potentially adverse consequences than traditional endoscopy (EGD), and it does not require capital equipment as magnetic endoscopy does. Flower offers the identification and location of bleeding sources in the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Fasting throughout Evaluation period | Experimental | In Group 1, participants will fast for 8 hours for food and 2 hours for clear fluids before undergoing a sedated EGD to confirm an empty stomach, serving as the ground truth. The procedure time, patient tolerance, presence or absence of gastric contents, and any adverse events (AEs) will be documented. After the fasting period and EGD, participants will consume 100 mL of water containing 400 mg of simethicone upon regaining full alertness. If necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will continue drinking until they feel full, with a typical intake ranging from 500 to 1400 mL of water. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. A blinded gastroenterologist, unaware of the participant's fasting Receives: Device: Flower |
| Group 2- Fasting till 8 hours and fed during Evaluation period | Experimental | In Group 2, participants will follow the same fasting protocol as Group 1, with 8 hours of fasting for food and 2 hours for clear fluids, followed by a sedated EGD to confirm an empty stomach. The procedure time, patient tolerance, presence or absence of gastric contents, and AEs will be documented. After the fasting period and EGD, participants will consume 1.5 mL/kg of a standardized food mixture -representing the minimum volume associated with high aspiration risk-once participants have fully regained alertness. Participants will consume 100 mL of water with 400 mg of simethicone. As in Group 1, if necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which they will continue drinking until they feel full, with a typical intake ranging from 500 to 1000 mL of water. Receives: Device: Flower |
| GLP 1 Participants | Experimental | Participants will continue taking their GLP-1 medication up to the day of the procedure. The participant will arrive at the hospital in the morning after following a 8 hour food fast and 2 hours for clear fluids. Following the fasting period, they will consume 100 mL of water containing 400 mg of simethicone. If necessary, participants should engage in light walking and avoid prolonged sitting. A 10-minute waiting period will then ensue, after which they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will be instructed to drink at least 500 mL of water, continuing until a sensation of fullness is reached, with a typical total intake ranging from 500 mL to 1400 mL. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. The Flower capsule will then be administered. Receives: Device: Flower |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Retained Gastric Contents Using Flower Capsule
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).
Measured: Within 1 hour post-capsule ingestion
Secondary outcomes (8)
Visualization of Gastric Anatomical Landmarks
Number of gastric landmarks (fundus, cardia, lesser curvature, greater curvature, angulus, antrum, pylorus) successfully visualized using the Flower capsule.
Measured: Within 1 hour post-capsule ingestion
Gastric Mucosal Visualization Score
Quality of mucosal visualization at each landmark based on a 4-point scale (1 = Poor, 4 = Excellent).
Measured: Within 1 hour post-capsule ingestion
Gastric Cleanliness Score
Degree of gastric cleanliness based on a 4-point scale (1 = Poor, 4 = Excellent).
Measured: Within 1 hour post-capsule ingestion
Adverse Events Related to Flower Capsule
Number of participants with any of the following adverse events: capsule retention, aspiration, nausea, pain, perforation.
Measured: From Day 0 to Day 14
Time to Complete Gastric Examination
Total time required to complete Flower capsule-based gastric examination.
Measured: Within 1 hour post-capsule ingestion
Capsule Swallowing Success
Number of attempts required to successfully swallow the Flower capsule.
Measured: Within 15 minutes of capsule administration
Total Water Volume Consumed
Total volume of water consumed to achieve adequate gastric distention prior to Flower examination.
Measured: Prior to capsule ingestion
Patient Tolerance Score for Flower Capsule
Participant-reported tolerance using a 10-point scale (1 = best experience, 10 = worst experience).
Measured: Immediately after Flower capsule examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start8 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Endoscopy, Digestive SystemStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- Endiatx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927401
- Sponsor's protocol ID
- ETX-IND-01
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khandekar SS, Doctor JR, Awaskar SK, Alex NK, Medha LR, Ranganathan P. Ultrasound-guided estimation of gastric residual volume using Perlas's formula: A validation study in patients. Indian J Anaesth. 2022 Apr;66(4):255-259. doi: 10.4103/ija.ija_783_21. Epub 2022 Apr 20.
PubMed 35663207Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
PubMed 36870274Heckmann ND, Palmer R, Mayfield CK, Gucev G, Lieberman JR, Hong K. Glucagon-Like Peptide Receptor-1 Agonists Used for Medically-Supervised Weight Loss in Patients With Hip and Knee Osteoarthritis: Critical Considerations for the Arthroplasty Surgeon. Arthroplast Today. 2024 Jun 27;27:101327. doi: 10.1016/j.artd.2024.101327. eCollection 2024 Jun.
PubMed 39071832Chaitra TS, Palta S, Saroa R, Jindal S, Jain A. Assessment of residual gastric volume using point-of-care ultrasonography in adult patients who underwent elective surgery. Ultrasound J. 2023 Feb 8;15(1):7. doi: 10.1186/s13089-023-00307-8.
PubMed 36752856Warner MA, Meyerhoff KL, Warner ME, Posner KL, Stephens L, Domino KB. Pulmonary Aspiration of Gastric Contents: A Closed Claims Analysis. Anesthesiology. 2021 Aug 1;135(2):284-291. doi: 10.1097/ALN.0000000000003831.
PubMed 34019629Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
PubMed 30443057Son YG, Shin J, Ryu HG. Pneumonitis and pneumonia after aspiration. J Dent Anesth Pain Med. 2017 Mar;17(1):1-12. doi: 10.17245/jdapm.2017.17.1.1. Epub 2017 Mar 27.
PubMed 28879323
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06927401
- Acronym / sponsor ID
- ETX-IND-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- Endiatx
- Study start
- 8 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Study Purpose
- 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.
- Study Endpoints
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1-Fasting throughout Evaluation period | Experimental | Device: FlowerIn Group 1, participants will fast for 8 hours for food and 2 hours for clear fluids before undergoing a sedated EGD to confirm an empty stomach, serving as the ground truth. The procedure time, patient tolerance, presence or absence of gastric contents, and any adverse events (AEs) will be documented. After the fasting period and EGD, participants will consume 100 mL of water containing 400 mg of simethicone upon regaining full alertness. If necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will continue drinking until they feel full, with a typical intake ranging from 500 to 1400 mL of water. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. A blinded gastroenterologist, unaware of the participant's fasting |
| Group 2- Fasting till 8 hours and fed during Evaluation period | Experimental | Device: FlowerIn Group 2, participants will follow the same fasting protocol as Group 1, with 8 hours of fasting for food and 2 hours for clear fluids, followed by a sedated EGD to confirm an empty stomach. The procedure time, patient tolerance, presence or absence of gastric contents, and AEs will be documented. After the fasting period and EGD, participants will consume 1.5 mL/kg of a standardized food mixture -representing the minimum volume associated with high aspiration risk-once participants have fully regained alertness. Participants will consume 100 mL of water with 400 mg of simethicone. As in Group 1, if necessary, they may engage in light walking and avoid prolonged sitting. After a 10-minute waiting period, they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which they will continue drinking until they feel full, with a typical intake ranging from 500 to 1000 mL of water. |
| GLP 1 Participants | Experimental | Device: FlowerParticipants will continue taking their GLP-1 medication up to the day of the procedure. The participant will arrive at the hospital in the morning after following a 8 hour food fast and 2 hours for clear fluids. Following the fasting period, they will consume 100 mL of water containing 400 mg of simethicone. If necessary, participants should engage in light walking and avoid prolonged sitting. A 10-minute waiting period will then ensue, after which they will consume an additional 100 mL of water and attempt to empty their bladder. Another 10-minute waiting period will follow, during which participants will be instructed to drink at least 500 mL of water, continuing until a sensation of fullness is reached, with a typical total intake ranging from 500 mL to 1400 mL. If gastric distention is insufficient, additional water ingestion will be required, with the total volume documented. The Flower capsule will then be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- History of gastrointestinal disorders
- History of gastroparesis
- History of prior gastric surgery
- Swallowing disorders
- Contraindications to EGD or capsule endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowerFlower is a single-use capsule endoscope designed for timely visualization of the human stomach. The patient drinks water to fill the stomach before swallowing the Flower capsule, which transmits wireless video, through an external dongle placed near the patient's abdomen, to a physician's computer or smartphone. Flower is weighted to orientationally bias the capsule upward, meaning that with a few simple position adjustments a complete viewing of the stomach can be achieved approximately 10 minutes. The procedure requires no sedation or equipment other than the Flower System (capsule and dongle). As a simple means of screening, Flower functions equivalent to comparable technologies, but offers advantages of being less invasive and burdensome. Flower has fewer potentially adverse consequences than traditional endoscopy (EGD), and it does not require capital equipment as magnetic endoscopy does. Flower offers the identification and location of bleeding sources in the stomach. | Device | GLP 1 Participants, Group 1-Fasting throughout Evaluation period, Group 2- Fasting till 8 hours and fed during Evaluation period |
Primary outcome
Detection of Retained Gastric Contents Using Flower Capsule
Time frame: 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).
8 secondary outcomes
Visualization of Gastric Anatomical Landmarks
Time frame: Within 1 hour post-capsule ingestion
Gastric Mucosal Visualization Score
Time frame: Within 1 hour post-capsule ingestion
Gastric Cleanliness Score
Time frame: Within 1 hour post-capsule ingestion
Adverse Events Related to Flower Capsule
Time frame: From Day 0 to Day 14
Time to Complete Gastric Examination
Time frame: Within 1 hour post-capsule ingestion
Capsule Swallowing Success
Time frame: Within 15 minutes of capsule administration
Total Water Volume Consumed
Time frame: Prior to capsule ingestion
Patient Tolerance Score for Flower Capsule
Time frame: Immediately after Flower capsule examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 35663207Khandekar SS, Doctor JR, Awaskar SK, Alex NK, Medha LR, Ranganathan P. Ultrasound-guided estimation of gastric residual volume using Perlas's formula: A validation study in patients. Indian J Anaesth. 2022 Apr;66(4):255-259. doi: 10.4103/ija.ija_783_21. Epub 2022 Apr 20.
- Background: PubMed 36870274Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
- Background: PubMed 39071832Heckmann ND, Palmer R, Mayfield CK, Gucev G, Lieberman JR, Hong K. Glucagon-Like Peptide Receptor-1 Agonists Used for Medically-Supervised Weight Loss in Patients With Hip and Knee Osteoarthritis: Critical Considerations for the Arthroplasty Surgeon. Arthroplast Today. 2024 Jun 27;27:101327. doi: 10.1016/j.artd.2024.101327. eCollection 2024 Jun.
- Background: PubMed 36752856Chaitra TS, Palta S, Saroa R, Jindal S, Jain A. Assessment of residual gastric volume using point-of-care ultrasonography in adult patients who underwent elective surgery. Ultrasound J. 2023 Feb 8;15(1):7. doi: 10.1186/s13089-023-00307-8.
- Background: PubMed 34019629Warner MA, Meyerhoff KL, Warner ME, Posner KL, Stephens L, Domino KB. Pulmonary Aspiration of Gastric Contents: A Closed Claims Analysis. Anesthesiology. 2021 Aug 1;135(2):284-291. doi: 10.1097/ALN.0000000000003831.
- Background: PubMed 30443057Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
- Background: PubMed 28879323Son YG, Shin J, Ryu HG. Pneumonitis and pneumonia after aspiration. J Dent Anesth Pain Med. 2017 Mar;17(1):1-12. doi: 10.17245/jdapm.2017.17.1.1. Epub 2017 Mar 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB contact
Nitin Jagtap Senior Consultant Gastroenterology, MBBS, MD, DNB contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flower in people with Endoscopy, Digestive System and GLP1-R-related Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB (040 4244 4222, drrakeshkalapala@aighospitals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Retained Gastric Contents Using Flower Capsule (time frame: Within 1 hour post-capsule ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927401, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.