Clinical Evaluation of the CM-1500 During Hemodialysis

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.

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