Clinical Evaluation of the CM-1500 During Hemodialysis

Zynex Monitoring Solutions

Status: Completed

Conditions: Dialysis; Fluid Loss

Treatments: Device: CM-1500

Study type: Interventional

Funder types: Industry

Identifiers

NCT05125848

ZMS-1500-2021-Dialysis

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Hemodialysis Single Group Assignment

Experimental group

Description:

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

Treatment:

Device: CM-1500