Sensor-based Congestion ALert for Events in Peritoneal Di... | NCT07059962

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

NCT07059962

Sponsor

Bodyport Inc.

Status

Recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

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

Interventions

Bodyport Cardiac Scale

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2025Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Jun 24, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD Patients		Patients with kidney disease on peritoneal dialysis.	Device: Bodyport Cardiac Scale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity Analysis	Sensitivity for predicting usable PDE > 0.40 and an alert rate of < 4.3 alerts per patient-year.	1 year

Secondary Outcomes

Measure	Description	Time Frame
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.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Corey Centen	Contact	415-990-5415		corey@bodyport.com
Dorothy Kwok	Contact	669-240-3077		dorothy@bodyport.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Desert Cities Dialysis	Recruiting	Victorville	California	92395	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases
D007676	Kidney Failure, Chronic
D004487	Edema
D006333	Heart Failure

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided