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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)

NCT07059962 · Bodyport Inc.
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Official title
Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. Age 21 years or older 2. 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 3. Able to stand on two bare feet unassisted 4. Receiving automated peritoneal dialysis for the treatment of ESKD 5. Followed on the Vantive Sharesource Remote Patient Management Platform Exclusion Criteria: 1. Undergoing or plan to undergo hemodialysis in the next 12 months 2. Have a life expectancy of less than 12 months 3. Are pregnant or plan to become pregnant during the next 12 months 4. Weigh greater than 375 lbs 5. Planned kidney transplant within the next 12 months 6. Have an implanted neurostimulator system
Study design
Enrollment target: 125 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-09-09
Estimated completion: 2026-06
Last updated: 2026-03-18
Interventions
Device: Bodyport Cardiac Scale
Primary outcomes
  • Sensitivity Analysis (1 year)
Sponsor
Bodyport Inc. · industry
Contacts & investigators
ContactCorey Centen · contact · corey@bodyport.com · 415-990-5415
ContactDorothy Kwok · contact · dorothy@bodyport.com · 669-240-3077
All locations (4)
Desert Cities DialysisRecruiting
Victorville, California, United States
Southeastern Clinical Research InstituteRecruiting
Augusta, Georgia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Seven Oaks General HospitalRecruiting
Winnipeg, Manitoba, Canada