Clinical Evaluation of the CM-1500 During Hemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-03-04

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.

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Detailed Description

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Conditions

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Fluid Loss Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hemodialysis Single Group Assignment

All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session

Group Type EXPERIMENTAL

CM-1500

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No