Fluid Status of ESRD Patients Undergoing Dialysis

HemoCept Inc.

Status: Completed

Conditions: ESRD (End Stage Renal Disease)

Study type: Observational

Funder types: Industry

Identifiers

NCT07217470

PRT-017

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.