[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FluidAI Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"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":18,"type":19},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.",[23],"Gastrointestinal Diseases","RECRUITING","2025-03-10",{"date":27,"type":28},"2025-03-12","ACTUAL",{"date":30,"type":28},"2024-11-19",{"date":32,"type":19},"2025-07",{"name":34,"class":35},"FluidAI Medical","INDUSTRY",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":36},"100556204","evaluating-the-effective-and-safe-use-of-stream-platform-100556204","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).","18 Years",{"count":47,"type":19},25,"INTERVENTIONAL",[50],"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.",[53,54,55,56],"User-Centered Design","Anastomotic Leak","Colorectal Surgery","Artificial Intelligence",[54,56,55,58,59],"ERAS","Stream Platform","NOT_YET_RECRUITING","2025-02-26",{"date":63,"type":28},"2025-02-28",{"date":65,"type":19},"2025-03-15",{"date":67,"type":19},"2025-12-30",{"name":34,"class":35},""]