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

NCT ID: NCT07059962

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD Patients

Patients with kidney disease on peritoneal dialysis.

Bodyport Cardiac Scale

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bodyport Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Desert Cities Dialysis

Victorville, California, United States

Site Status RECRUITING

Southeastern Clinical Research Institute

Augusta, Georgia, United States

Site Status RECRUITING

aQua Research Institute, LLC

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Corey Centen

Role: CONTACT

415-990-5415

Dorothy Kwok

Role: CONTACT

669-240-3077

Facility Contacts

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Heberto Schramm

Role: primary

(760) 998 - 2060

Jaewon Lee

Role: primary

706-922-3005

Rocio Hernandez

Role: primary

682-774-5807

Other Identifiers

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CP-ScalePD-01

Identifier Type: -

Identifier Source: org_study_id

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