[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659711":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":35,"interventions":41,"overallOfficials":28,"centralContacts":46,"locations":52,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":28,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":93,"conditions":94,"keywords":28,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Stony Brook University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Sensitivity and specificity","To determine the clinical relationship (sensitivity \\& specificity) of blood detection in the upper GI lumen between the HemoPill acute (trial) and endoscopic examination (control).","From enrollment to the end of the endoscopic examination.",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Clinical effectiveness - Predictive Values","To demonstrate the Negative and Positive Predictive Values by indicating the presence\u002Fabsence of blood in the upper GI tract.",{"measure":18,"description":19,"timeFrame":20},"Transit and excretion","Determination of capsule presence\u002Fabsence via X-ray radiography \\& HemoPill acute receiver connectivity.","At Follow-up Visit 1 7-14 days post-ingestion and Follow-up Visit 2 15-21 days post-ingestion (if needed).",{"measure":22,"description":23,"timeFrame":12},"Technical effectiveness","To determine rate of successful data transmission of the HemoPill acute to the HemoPill receiver.",{"measure":25,"description":26,"timeFrame":27},"Safety profile and complications","To determine the safety profile or rate of adverse events\u002Fserious adverse events\u002Fcomplications of the HemoPill acute.","From enrollment to Follow-up Visit 1 7-14 days post-ingestion or Follow-up Visit 2 15-21 days post-ingestion (if needed).",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE",[36],{"label":37,"type":38,"description":28,"interventionNames":39},"HemoPill acute","EXPERIMENTAL",[40],"Device: HemoPill acute",[42],{"type":43,"name":37,"description":44,"armGroupLabels":45,"otherNames":28},"DEVICE","Participants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.",[37],[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Joseph LaComb","CONTACT","631-444-9532","joseph.lacomb@stonybrookmedicine.edu",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Stony Brook","New York","11794","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-73.14094,40.92565,{"lat":64,"lon":63},[67,68],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},{"name":69,"role":70,"phone":28,"phoneExt":28,"email":28},"Vivek Kesar, MBBS","PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Vivek Kesar","Assistant Professor of Medicine",[75],{"name":76,"class":77},"Ovesco Endoscopy AG","INDUSTRY","100659711","detection-of-blood-in-the-gi-lumen-with-hemopill-acute-100659711",false,"NCT07868068","Detection of Blood in the GI Lumen With HemoPill Acute","Detection of Blood in the GI Lumen With HemoPill Acute - Relation Between Endoscopy and HemoPill Acute Measurement","DIRECT","Inclusion Criteria:\n\n* Greater than or equal to 22 years of age.\n* Scheduled for upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care.\n* Literate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Less than 22 years of age.\n* Not undergoing upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care.\n* Contraindications to the use of the HemoPill acute including:\n\n  1. Known GI obstruction, stricture, or fistula;\n  2. Dysphagia, Zenker's diverticulum, or other swallowing disorders;\n  3. Achalasia or other esophageal dysmotility.\n* Cardiac pacemakers or other implanted electrical device(s).\n* Circulatory or hemodynamic instability at the discretion\u002Fdetermination of the attending endoscopist and clinical care team.\n* Pregnant or breastfeeding.\n* Not literate or unable to provide written informed consent.","ALL","22 Years",{"count":89,"type":90},50,"ESTIMATED","INTERVENTIONAL",[30],"The goal of this clinical trial is to learn if the HemoPill acute (trial device) can detect the presence of blood in participants suspected of having upper gastrointestinal bleeding. The main question it aims to answer is:\n\n-What is the clinical relationship between the HemoPill acute (trial device) and endoscopy (control procedure) in detecting the presence of blood\u002Fbleeding in the upper gastrointestinal tract?\n\nParticipants will:\n\n* Swallow the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.\n* Keep the device receiver close to their body from the time of swallowing until completion of their endoscopy procedure.\n* Return for a follow-up visit(s) to check for the presence or absence of the HemoPill acute device and to report the occurrence of any adverse or serious adverse events.",[95],"Upper GI Bleeding","2026-10-05",{"date":98,"type":99},"2026-10-09","ACTUAL",{"date":101,"type":90},"2026-10",{"date":103,"type":90},"2027-10",{"name":5,"class":6},1]