Clinical Evaluation of the CM-1500 During Hemodialysis

Completed · Not applicable

Conditions studied: Fluid Loss, Dialysis

In brief

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.

Key facts

Study ID

NCT05125848

Run by

Zynex Monitoring Solutions

People needed

15

Starts

2021-11-29

Expected to finish

2022-03-04

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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