[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557693":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":10,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"FluidAI Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sample Collection Cohort",null,"This group will contain patients that undergo gastrointestinal surgeries, namely hepatobiliary, colorectal, trauma, and acute care procedures, and received an abdominal drain. Samples of abdominal drainage fluid will be collected daily from each patient.",[13],"Other: Abdominal Drainage Fluid Collection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","Abdominal Drainage Fluid Collection","Abdominal drainage fluid will be collected daily from the subjects until they are discharged from the hospital, or their abdominal\u002Fpelvic drain is removed, as determined by the treating surgeon.",[9],[21],{"name":22,"affiliation":23,"role":24},"Dr Pablo Serrano, MD MPH FACS","Juravinski Hospital - Hamilton Health Sciences","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","(905) 521-2100","43872","serrano@mcmaster.ca",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Juravinski Hospital","RECRUITING","Hamilton","Ontario","L8V1C3","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-79.84963,43.25011,{"lat":44,"lon":43},[47,51,54],{"name":48,"role":27,"phone":49,"phoneExt":10,"email":50},"Allen Lian","905-962-1588","lianz1@mcmaster.ca",{"name":52,"role":27,"phone":10,"phoneExt":10,"email":53},"Elisabeth Lo","loe3@mcmaster.ca",{"name":55,"role":24,"phone":10,"phoneExt":10,"email":10},"Dr Pablo Serrano, MD, MSc, MPH",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59],{"name":60,"class":16},"Hamilton Health Sciences Corporation","100557693","analytical-validation-of-stream-platform-100557693",false,"NCT06541431","Analytical Validation of Stream™ Platform","Analytical Validation of Stream™ Platform - Sample Collection Protocol","Inclusion Criteria:\n\n* Age ≥ 18 years - male or female\n* Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)\n* Subjects must be willing to comply with trial requirements\n* Subject has performed an open or laparoscopic surgery with abdominal\u002F pelvic drainage\n\nExclusion Criteria:\n\n* Subject is expected to be discharged less than 8 hours post-surgery\n* Subject carries has a known infectious disease such as Hepatitis B or C, HIV, TB, infections caused by multi-drug resistant organisms, or known parasitic infections affecting the gastrointestinal tract\n* Involvement in the planning and conduct of the clinical investigation","ALL",{"count":70,"type":71},50,"ESTIMATED","OBSERVATIONAL","The accurate monitoring of physiological parameters in postoperative patients is essential for early detection and management of potential complications. One such critical parameter is the pH of abdominal drainage fluid, which can provide valuable insights into the patient's recovery and the presence of any postoperative infections or complications after gastrointestinal surgery. The Stream™ Platform, consisting of the Origin™ inline biosensor system and supporting materials, represents a significant advancement in this area. Origin™ is designed to be integrated inline with a standard surgical drain, enabling real-time monitoring of drainage effluent characteristics, specifically pH, which represents the acidity of the fluid.\n\nThis protocol details the analytical validation of the Stream™ Platform, focusing on the pH measurements conducted by the Origin™ device. The study aims to establish the precision, linearity, and analytical specificity of the Origin™ system. Additionally, method comparison studies will be conducted to evaluate the performance of the Origin™ device against standard bench-top comparators.\n\nThe multi-center study will be conducted using commercially available calibration fluids and abdominal drainage samples collected from patients undergoing abdominal surgeries. These samples, which include those from colorectal, hepatobiliary, and trauma and acute care patients, will be utilized to validate the Origin™ device's capability to deliver accurate and reliable pH measurements.",[75],"Gastrointestinal Diseases","2025-03-10",{"date":78,"type":79},"2025-03-12","ACTUAL",{"date":81,"type":79},"2024-11-19",{"date":83,"type":71},"2025-07",{"name":5,"class":6},1]