| CTRI Number |
CTRI/2025/04/084367 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Confirming Flower capsule performance characteristics in detection of retained gastric contents |
|
Scientific Title of Study
|
Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor
Agonist Users |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Kalapala |
| Designation |
Senior Consultant Gastroenterologist & Therapeutic Endoscopist |
| Affiliation |
Asian Institute of Gastroenterology Hospital |
| Address |
Asian Institute of Gastroenterology Hospital
Hyderabad, India,
Hyderabad
TELANGANA
500082
India |
| Phone |
04042444222 |
| Fax |
|
| Email |
drrakeshkalapala@aighospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kalapala |
| Designation |
Senior Consultant Gastroenterologist & Therapeutic Endoscopist |
| Affiliation |
Asian Institute of Gastroenterology Hospital |
| Address |
Asian Institute of Gastroenterology Hospital
Hyderabad, India,
Hyderabad
TELANGANA
500082
India |
| Phone |
04042444222 |
| Fax |
|
| Email |
drrakeshkalapala@aighospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Kalapala |
| Designation |
Senior Consultant Gastroenterologist & Therapeutic Endoscopist |
| Affiliation |
Asian Institute of Gastroenterology Hospital |
| Address |
Asian Institute of Gastroenterology Hospital
Hyderabad, India,
Hyderabad
TELANGANA
500082
India |
| Phone |
04042444222 |
| Fax |
|
| Email |
drrakeshkalapala@aighospitals.com |
|
|
Source of Monetary or Material Support
|
| Endiatx
25545 Whitesell St, Hayward, CA 94545, United States |
|
|
Primary Sponsor
|
| Name |
Endiatx |
| Address |
25545 Whitesell St, Hayward, CA 94545, United States |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kalapala |
Asian Institute of Gastroenterology Hospital |
Asian Institute of Gastroenterology Hospital
Hyderabad, India
Hyderabad
TELANGANA |
040 4244 4222
drrakeshkalapala@aighospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No history of gastrointestinal disorders, gastroparesis, or prior gastric surgery. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Esophagogastroduodenoscopy |
A procedure used to examine the lining of the esophagus, stomach, and the first part of the small intestine (duodenum).
Duration - 10 mins |
| Intervention |
Flower |
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.
Duration - 10 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements |
|
| ExclusionCriteria |
| Details |
No history of :
Gastrointestinal disorders, Gastroparesis, Prior gastric surgery, Swallowing disorders,
Contraindications to EGD or capsule endoscopy and
GLP-1 users in the last 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the detection of retained gastric contents and assess safety using the Flower Capsule Endoscopy in healthy
individuals and GLP-1 receptor agonist users outcome measures will be documented, including the visualization of retained gastric contents; identification of
all seven gastric anatomical landmarks—fundus, cardia, lesser gastric curvature, lesser gastric curvature, greater gastric curvature, angulus, antrum, and pylorus; evaluation of gastric mucosal visualization; assessment of gastric cleanliness; evaluation of patient tolerance; total water volume intake; number of attempts required for successful capsule swallowing; time to complete the gastric examination; and documentation of any adverse events, such as
capsule aspiration, nausea, or pain. |
2 Months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |