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Clinical Evaluation of the CM-1500 During Hemodialysis

Z

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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