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

NCT07059962 | Recruiting FDA Device

• 1 other identifier: CP-ScalePD-01
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

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

Keywords

kidney disease; peritoneal dialysis; fluid overload; heart failure

Outcome Measures

Primary Outcomes (1)

• Sensitivity Analysis

  Sensitivity for predicting usable PDE \> 0.40 and an alert rate of \< 4.3 alerts per patient-year.

  1 year

Secondary Outcomes (1)

• Peritoneal Dialysis (PD) Events

  1 year

Study Arms (1)

PD Patients

Patients with kidney disease on peritoneal dialysis.

Device: Bodyport Cardiac Scale

Interventions

Bodyport Cardiac Scale DEVICE

The Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.

PD Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females 21 years of age or older, with end stage kidney disease undergoing peritoneal dialysis.

You may qualify if:

• Age 21 years or older
• 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
• Able to stand on two bare feet unassisted
• Receiving automated peritoneal dialysis for the treatment of ESKD
• Followed on the Vantive Sharesource Remote Patient Management Platform

You may not qualify if:

• Undergoing or plan to undergo hemodialysis in the next 12 months
• Have a life expectancy of less than 12 months
• Are pregnant or plan to become pregnant during the next 12 months
• Weigh greater than 375 lbs
• Planned kidney transplant within the next 12 months
• Have an implanted neurostimulator system

Sponsors & Collaborators

• Bodyport Inc.: lead

Study Sites (4)

Desert Cities Dialysis

Victorville, California, 92395, United States

RECRUITING

Southeastern Clinical Research Institute

Augusta, Georgia, 30904, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Seven Oaks General Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Edema; Heart Failure

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Corey Centen

CONTACT

415-990-5415; corey@bodyport.com

Dorothy Kwok

CONTACT

669-240-3077; dorothy@bodyport.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 11, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)