[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07059962":3,"trial-entities:NCT07059962":126,"trial-summary:NCT07059962":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":49,"minimum_age":50,"maximum_age":28,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":114,"overall_officials":123,"references":124,"see_also_links":125},"NCT07059962","CP-ScalePD-01","Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)","Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)","RECRUITING","2026-06","2025-11","2026-03-18","2025-09-09","Bodyport Inc.","INDUSTRY",false,"To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.","The objective of this study is to explore the utility of hemodynamic biomarkers measured by the Bodyport Cardiac Scale in predicting worsening events attributable to fluid overload among those with kidney disease on peritoneal dialysis. The study will explore individual biomarkers, as well as composite biomarker indices, such as the Congestion Index and a novel PD Index.",[19,20,21],"Kidney Disease","Peritoneal Dialysis (PD)","End Stage Kidney Disease (ESRD)",[23,24,25,26],"kidney disease","peritoneal dialysis","fluid overload","heart failure","OBSERVATIONAL",null,[],{"count":31,"type":32},125,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Bodyport Cardiac Scale","The Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.",[39],"PD Patients",[41],{"measure":42,"description":43,"timeFrame":44},"Sensitivity Analysis","Sensitivity for predicting usable PDE \\> 0.40 and an alert rate of \\\u003C 4.3 alerts per patient-year.","1 year",[46],{"measure":47,"description":48,"timeFrame":44},"Peritoneal Dialysis (PD) Events","Collection of approximately 40 usable PD Events for model development and validation. These events are defined as urgent, unscheduled clinic visits or emergency department visits or hospital admissions for worsening fluid overload and initiation or intensification of treatment for fluid overload or termination of treatment due to fluid related cause.","ALL","21 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Age 21 years or older\n2. Able to speak and read English, or able to speak and read Spanish and has a caregiver or family member who speaks English and can provide assistance\n3. Able to stand on two bare feet unassisted\n4. Receiving automated peritoneal dialysis for the treatment of ESKD\n5. Followed on the Vantive Sharesource Remote Patient Management Platform\n\nExclusion Criteria:\n\n1. Undergoing or plan to undergo hemodialysis in the next 12 months\n2. Have a life expectancy of less than 12 months\n3. Are pregnant or plan to become pregnant during the next 12 months\n4. Weigh greater than 375 lbs\n5. Planned kidney transplant within the next 12 months\n6. Have an implanted neurostimulator system",[56,57],"ADULT","OLDER_ADULT",[59,74,87,100],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":71},"Desert Cities Dialysis","Victorville","California","92395","United States",[66],{"name":67,"role":68,"phone":69,"email":70},"Heberto Schramm","CONTACT","(760) 998 - 2060","hschramm@dcdialysis.com",{"lat":72,"lon":73},34.53611,-117.29116,{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":64,"contacts":79,"geoPoint":84},"Southeastern Clinical Research Institute","Augusta","Georgia","30904",[80],{"name":81,"role":68,"phone":82,"email":83},"Jaewon Lee","706-922-3005","jlee@scri.care",{"lat":85,"lon":86},33.47097,-81.97484,{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":64,"contacts":92,"geoPoint":97},"Northwestern University","Chicago","Illinois","60611",[93],{"name":94,"role":68,"phone":95,"email":96},"Alexis Stevenson","312-503-3901","alexis.stevenson@northwestern.edu",{"lat":98,"lon":99},41.85003,-87.65005,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":111},"Seven Oaks General Hospital","Winnipeg","Manitoba","R2V 3M3","Canada",[107],{"name":108,"role":68,"phone":109,"email":110},"Trang Nguyen","1-204-632-3661","tnguyen31@sogh.mb.ca",{"lat":112,"lon":113},49.8844,-97.14704,[115,119],{"name":116,"role":68,"phone":117,"email":118},"Corey Centen","415-990-5415","corey@bodyport.com",{"name":120,"role":68,"phone":121,"email":122},"Dorothy Kwok","669-240-3077","dorothy@bodyport.com",[],[],[],{"nct_id":4,"conditions":127,"biomarkers":132},[128,129,130,131],"Chronic Kidney Disease, Stage 5","Fluid Overload","Heart Failure","Peritoneal Dialysis",[],{"nct_id":4,"found":134,"summary":135,"prompt_version":145},true,{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an observational study, meaning researchers will watch and collect information without giving a specific treatment. It plans to include 125 participants.","completed","Exploring the Bodyport Cardiac Scale for Fluid Overload in Peritoneal Dialysis","This study is looking at how a device called the Bodyport Cardiac Scale can help predict problems caused by too much fluid in people with kidney disease who are on peritoneal dialysis (a type of treatment for kidney failure). The Bodyport Cardiac Scale measures different body signals to understand your fluid levels. The goal is to see if these measurements can tell us when fluid overload might lead to health issues. We are looking for people aged 21 or older who are receiving automated peritoneal dialysis and can stand on two bare feet without help. The study will measure how well the Bodyport Cardiac Scale predicts these events over one year. The current status of this study is unclear.","The study will measure how well the Bodyport Cardiac Scale predicts events over one year.",119,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]