Clinical Evaluation of the CM-1500 During Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of the CM-1500 During Hemodialysis

Conditions
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Fluid Loss, Dialysis

Intervention / Treatment
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* Device: CM-1500


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysis Single Group Assignment<br>All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session | Device: CM-1500<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize changes in the Relative Index During a Hemodialysis Procedure | The primary objective of the study is to characterize changes in the CM-1500 Relative Index over the duration of a hemodialysis procedure | 1-6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the intersubject and intrasubject variability in Relative Index changes across multiple hemodialysis sessions | The secondary objective of the study is to characterize the intersubject and intrasubject variability in Relative Index changes across the three hemodialysis sessions | 1-2 weeks |