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

NCT06927401 | Not Yet Recruiting DMC

• 1 other identifier: ETX-IND-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Endoscopy, Digestive System; GLP1-R-related Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 1 hour post-capsule ingestion

Secondary Outcomes (8)

• Visualization of Gastric Anatomical Landmarks

  Within 1 hour post-capsule ingestion

• Gastric Mucosal Visualization Score

  Within 1 hour post-capsule ingestion

• Gastric Cleanliness Score

  Within 1 hour post-capsule ingestion

• Adverse Events Related to Flower Capsule

  From Day 0 to Day 14

• Time to Complete Gastric Examination

  Within 1 hour post-capsule ingestion

Study Arms (3)

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

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.

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.

Device: Flower

Interventions

Flower DEVICE

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.

GLP 1 Participants; Group 1-Fasting throughout Evaluation period; Group 2- Fasting till 8 hours and fed during Evaluation period

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Endiatx: collaborator

Study Sites (1)

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, 500082, India

Location

Related Publications (7)

• 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.

  PMID: 35663207 BACKGROUND

• Silveira 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.

  PMID: 36870274 BACKGROUND

• Heckmann 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.

  PMID: 39071832 BACKGROUND

• Chaitra 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.

  PMID: 36752856 BACKGROUND

• Warner 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.

  PMID: 34019629 BACKGROUND

• Sharma 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.

  PMID: 30443057 BACKGROUND

• Son 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.

  PMID: 28879323 BACKGROUND

Central Study Contacts

Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB

CONTACT

040 4244 4222; drrakeshkalapala@aighospitals.com

Nitin Jagtap Senior Consultant Gastroenterology, MBBS, MD, DNB

CONTACT

040 4244 4222; docnits13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The anesthesia team will be blinded to the Flower findings, and the EGD will proceed according to the standard clinical care to determine the appropriate anesthesia type and airway management approach. After 2 hours, a sedated EGD will be performed. A blinded gastroenterologist will review the images to determine the presence or absence of gastric content. Patient tolerance and Adverse Events will be documented. To minimize bias, the gastroenterologist interpreting the EGD images will be blinded to the finding of the Flower capsule.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 15, 2025
• Study Start: April 8, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)