Clinical Evaluation of the CM-1500 During Hemodialysis

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.

Study Overview

• Status: Completed
• Conditions: Dialysis; Fluid Loss
• Intervention / Treatment: Device: CM-1500

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Davita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to provide written informed consent
• Ability and willingness to comply with the study procedures and duration requirements, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session
• 18 years of age or older
• Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Undergone an amputation of the left upper extremity
• Subjects with left arm hemodialysis access only
• Diagnosed with dextrocardia
• Subjects who have a pacemaker
• Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodialysis Single Group Assignment; All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session	Device: CM-1500; The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Relative Index Value Following a Hemodialysis Procedure	The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.	Duration of post-hemodialysis recovery period (10-minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions	The secondary objective is to characterize intrasubject variability in RI changes across 3 hemodialysis sessions. Cohort intrasubject variability was calculated by averaging individual subject standard deviations across enrollments. Variability for each subject is calculated by finding the RI mean and standard deviation for all RI values (1 per sec) during all 3 monitoring sessions. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max. where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.	Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions	The secondary objective is to characterize intersubject variability in RI changes across 3 hemodialysis sessions. Intersubject variability was calculated by finding the mean and standard deviation of the variability (standard deviation) from the mean RI values (1 value per sec) for each hemodialysis session monitoring period (3 sessions x 15 subjects = 45 individual monitoring sessions). The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max., where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.	Duration of standard dialysis procedure (Range: 131 to 241 minutes)

Collaborators and Investigators

• Sponsor: Zynex Monitoring Solutions
• Investigators: Principal Investigator: Jonathan Tolins, MD, Intermed Consultants

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): March 4, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZMS-1500-2021-Dialysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No