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Completed

NCT Number: NCT07217470

Fluid Status of ESRD Patients Undergoing Dialysis

The pilot clinical study will assess the correlation between fluid removal during dialysis and HemoCept device data.

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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

  • Subject 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 able and willing 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

  1. Correlation between dry weight changes and HemoCept device measurements.

    Time frame: Before and after one dialysis session, over the course of 1 day

    The primary analysis will be conducted using HemoCept device readings taken before dialysis and at the end of dialysis, just prior to return of blood and fluid from the machine. The device data will then be assessed for its comparison to dry weight changes.

Secondary outcomes

  1. Device related adverse events, and the possible correlation of skin tone to device results.

    Time frame: Before and after 1 dialysis session, over the course of 1 day.

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

    --Exploratory correlation of skin tone and device performance: Monk Skin Tone data will be collected to explore potential correlation between subject skin tone and HemoCept device readings.

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 16, 2025
Registry last updated
Dec 2, 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.

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