NCT07059962

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: Bodyport Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Disease
• Peritoneal Dialysis (PD)
• End Stage Kidney Disease (ESRD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-07-11
• Last updated: 2026-03-18

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study