[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":45,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Tan Tock Seng Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PillSense group","EXPERIMENTAL","Participants in the PillSense arm will swallow one PillSense capsule. Participants who have blood detected will be admitted with a scheduled oesophagogastroduodenoscopy within 72 hours. Participants with no blood detected will be discharged with medications and a scheduled OGD within 96 hours.",[13],"Device: PillSense System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard group","NO_INTERVENTION","Participants randomized to the standard arm will follow standard of care and will either be admitted or discharged with medications and to undergo an oesophagogastroduodenoscopy (OGD) within 72 hours if admitted or 96 hours if discharged.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","PillSense System","The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display. The PillSense Capsule is a minimally invasive, single use medical device designed to detect the presence of bleeding in the upper digestive tract, to aid with patient care. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule within 10 minutes. The PillSense Receiver interprets the data and displays a result message \"Blood detected\" or \"No blood detected\".",[9],[26],{"name":27,"affiliation":5,"role":28},"Dr Ng Wee Khoon","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+65 8938 1462","wee_khoon_ng@ttsh.com.sg",[35],{"facility":5,"status":36,"city":37,"state":18,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":18},"RECRUITING","Singapore","SG",{"type":40,"coordinates":41},"Point",[42,43],103.85007,1.28967,{"lat":43,"lon":42},{"type":28,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Wee Khoon Ng","Senior Consultant",[49],{"name":50,"class":51},"EnteraSense Limited","INDUSTRY","100554544","pillsense-for-suspected-upper-gastrointestinal-bleeding-100554544",false,"NCT06500468","PillSense for Suspected Upper Gastrointestinal Bleeding","Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding","BLEED","Inclusion Criteria:\n\n* Males or females aged 21 years and above and are able to give consent.\n* Patients who are willing and able to comply with the study protocol (including undergoing endoscopy)\n* Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting and melena (but without melaena on physical examination)\n\nExclusion Criteria:\n\n* Patients who had hemodynamic shock (systolic blood pressure below 90 mm Hg and pulse rate over 120\u002Fmin)\n* Patients who presented with fresh hematemesis, hematochezia and\u002For melaena\n* Patients requiring urgent endoscopy \u002F surgery at time of review or already planned for admission by ED physician for non UGIB related indications\n* Patients who had conditions that might contraindicate the use of an ingestible capsule, such as capsule endoscopy (eg. Dysphagia, odynophagia, swallowing disorder, and\u002For Zenker's diverticulum, issues with the motility of the gastrointestinal tract, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction and\u002For perforation)\n* Patients with a known history of oesophageal or gastric varices\n* Patients with known UGI pathology (such as oesophageal\u002Fgastric cancer), or recent (within 3 months) upper GI ulcer bleeding, upper GI surgeries or procedures\n* Patients who are on anticoagulation\n* Patients with cardiac implantable electrical device (CIED)\n* Patients who had altered mental status\n* Pregnant and\u002For lactating women (Female patients below age 60, without history of hysterectomy or are not documented to be post-menopausal, will be given a urine pregnancy test to confirm they are not pregnant)\n* Patients who have an MRI investigation planned within 2 weeks","ALL","21 Years","99 Years",{"count":64,"type":65},84,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.",[71],"Bleeding Ugi",[73,74,75,76,77,78],"capsule endoscopy","upper gastrointestinal bleeding","melena","coffee ground vomitting","emergency department","triage","2024-12-05",{"date":81,"type":82},"2024-12-10","ACTUAL",{"date":84,"type":82},"2024-07-18",{"date":86,"type":65},"2026-01",{"name":5,"class":6},1]