[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587362":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":28,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":28,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":28,"overallStatus":86,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Device: Flower",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2- Fasting till 8 hours and fed during Evaluation period","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\u002Fkg 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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"GLP 1 Participants","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.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Flower","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.\n\nThe 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.",[19,9,15],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Rakesh Kalapala Senior Consultant Gastroenterologist & Therapeutic Endoscopist, MBBS, MD, DNB","CONTACT","040 4244 4222","drrakeshkalapala@aighospitals.com",{"name":36,"role":32,"phone":33,"phoneExt":28,"email":37},"Nitin Jagtap Senior Consultant Gastroenterology, MBBS, MD, DNB","docnits13@gmail.com",[39],{"facility":40,"status":28,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Asian Institute of Gastroenterology Hospital","Hyderabad","Telangana","500082","India","IN",{"type":47,"coordinates":48},"Point",[49,50],78.45636,17.38405,{"lat":50,"lon":49},[53,54,56,58],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"name":31,"role":55,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":57,"role":55,"phone":28,"phoneExt":28,"email":28},"Nitin Jagtap Senior Consultant Gastroenterologist, MBBS, MD, DNB",{"name":59,"role":55,"phone":28,"phoneExt":28,"email":28},"Hardik Rughwani Senior Consultant Gastroenterologist, MBBS, MD, DNB",{"type":61,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[63],{"name":64,"class":65},"Endiatx","INDUSTRY","100587362","evaluate-the-detection-of-retained-gastric-contents-and-assess-safety-using-the-flower-capsule-endoscopy-in-healthy-individuals-and-glp-1-receptor-agonist-users-100587362",false,"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","Inclusion Criteria:\n\n1. Age \\> 18 years and \\\u003C 65 years (male or female)\n2. Willing and able to sign an IEC-approved informed consent form\n3. Willing and able to comply with all study requirements\n\nExclusion Criteria:\n\n1. History of gastrointestinal disorders\n2. History of gastroparesis\n3. History of prior gastric surgery\n4. Swallowing disorders\n5. Contraindications to EGD or capsule endoscopy\n6. Use of GLP-1 receptor agonists in the last 3 months\n7. Diagnosed with diabetes mellitus\n8. Classified as obese (based on BMI criteria)\n9. Pregnant or lactating",true,"ALL","18 Years","65 Years",{"count":77,"type":78},36,"ESTIMATED","INTERVENTIONAL",[81],"NA","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\u002Fkg in Healthy volunteers\n\n1\\. Study Purpose\n\na. 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.\n\n2\\. Study Endpoints\n\na. 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",[84,85],"Endoscopy, Digestive System","GLP1-R-related Disease","NOT_YET_RECRUITING","2025-04-14",{"date":89,"type":90},"2025-04-15","ACTUAL",{"date":92,"type":78},"2025-04-08",{"date":94,"type":78},"2025-08-30",{"name":5,"class":6},1]