Fluid Status of Dialysis Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ESRD (End Stage Renal Disease) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sierra Nevad Specialty Care

Reno, Nevada, 89511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Correlation between HemoCept device and changes in dry weight.

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

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.

Secondary outcomes

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

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

All secondary endpoints will be summarized descriptively, and no hypothesis tests are planned.

Sponsors and collaborators

Lead sponsor

HemoCept Inc.

Industry

Registry information

Official study title

A Pilot Clinical Study to Assess the Correlation Between Fluid Removal During Dialysis and HemoCept Device Data

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 15, 2025
Registry last updated: Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed