Fluid Status of Dialysis Subjects

NCT07217041 | Completed

• 1 other identifier: PRT-010
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.

Conditions

ESRD (End Stage Renal Disease)

Outcome Measures

Primary Outcomes (1)

• Correlation between HemoCept device and changes in dry weight.

  The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment.

  At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.

Secondary Outcomes (1)

• Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure

  From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria

You may qualify if:

• Study or representatives must have voluntarily signed the informed consent form before any study related procedures
• Subjects can be any gender, but must be between (and including) 18 and 75 years of age
• Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease
• Subject is willing and able to provide informed consent and HIPAA authorization • Subject is able and willing to meet all study requirements
• Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist

You may not qualify if:

• Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
• Subject has a personal medical history that includes:
• Long Q-T syndrome
• Cardiac channelopathies, genetic heart defects
• Seizures
• Acute untreated blood clotting disorders or acute untreated bleeding disorders
• Subject has had a heart transplant.

Sponsors & Collaborators

• HemoCept Inc.: lead

Study Sites (1)

Sierra Nevad Specialty Care

Reno, Nevada, 89511, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 15, 2025
• Study Start: March 19, 2025
• Primary Completion: May 12, 2025
• Study Completion: June 9, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)