[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556204":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"FluidAI Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Stream™ Platform will be attached to the abdominal\u002Fpelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid.\n\nAll subjects recruited will take part in the evaluation of Stream™ Platform in a simulated home-use environment.",[13],"Device: Stream™ Platform",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Stream™ Platform","Stream™ Platform consists of 5 main components: Origin™, Delta™ Monitor, Stream™ Application, Accessory Calibration Syringe(s), and Stream™ Cart. Origin™ is an inline biosensor system that can be attached between an off-the-shelf drainage catheter and evacuator bag\u002Fbulb system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) for the early identification of postoperative complications. Origin™ requires daily calibration (via Accessory Calibration Syringe(s)) for optimal performance and accuracy of its sensors. The Stream Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor) that are supplied by FluidAI. Origin connects to Stream Application via Bluetooth. Mobile carts\u002Fmounts, denoted Stream™ Carts\u002FDelta Mounts, will be used to house the Delta™ Monitor.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Carl J Brown, BSc MSc MD FRCSC","CONTACT","604-682-2344","cbrown@providencehealth.bc.ca",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"St. Paul's Hospital - Providence Healthcare (PHC)","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":36,"coordinates":37},"Point",[38,39],-123.11934,49.24966,{"lat":39,"lon":38},[42,43,46,48,50],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":44,"role":24,"phone":20,"phoneExt":20,"email":45},"Elizabeth Clement, BSc MSc MD FRCSC","eclement1@providencehealth.bc.ca",{"name":23,"role":47,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":44,"role":49,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":51,"role":49,"phone":20,"phoneExt":20,"email":20},"Amandeep (Anu) Ghuman, BSc MD MPH FRCSC",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100556204","evaluating-the-effective-and-safe-use-of-stream-platform-100556204",false,"NCT06522061","Evaluating the Effective and Safe Use of Stream™ Platform","Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment","Home-Stream","Inclusion Criteria:\n\n* Age ≥ 18 years - male or female.\n* Subject\u002FSDM understands and has voluntarily signed and dated Informed Consent Form (ICF).\n* Subject underwent colorectal surgery with anastomosis.\n* Subjects must be willing to comply with trial requirements.\n* Subject has a prophylactic abdominal\u002Fpelvic drain after colorectal surgery.\n\nExclusion Criteria:\n\n* Subjects\u002Fcaregiver is unwilling or unable to comply with the requirements of the protocol.\n* 24 hours or more have passed since the end of the subject's surgery and consent was not attained.\n* The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.\n* Plans that the subject will be discharged in less than 3 days post-surgery.\n* Subject has reported that they are pregnant.\n* Subject has a permanent end stoma.\n* Subject is delirious.\n* Subject has severe dementia.\n* Subject was involved in the planning and conduct of the clinical investigation.\n* Origin™ is not compatible with the drain used on the subject.\n* Subject and\u002For caregiver is\u002Fare not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC\u002FHCP\u002Fother research staff).\n* The subject and\u002For caregiver is\u002Fare unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC\u002Finvestigator\u002Fother research staff).","ALL","18 Years",{"count":65,"type":66},25,"ESTIMATED","INTERVENTIONAL",[69],"NA","The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use.\n\nAdditionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.",[72,73,74,75],"User-Centered Design","Anastomotic Leak","Colorectal Surgery","Artificial Intelligence",[73,75,74,77,78],"ERAS","Stream Platform","NOT_YET_RECRUITING","2025-02-26",{"date":82,"type":83},"2025-02-28","ACTUAL",{"date":85,"type":66},"2025-03-15",{"date":87,"type":66},"2025-12-30",{"name":5,"class":6},1]