CompletedNot Applicable

Clinical Evaluation of the CM-1500 During Hemodialysis

United States15 participantsStarted 2021-11-29

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Average Relative Index Value Following a Hemodialysis Procedure

Timeframe: Duration of post-hemodialysis recovery period (10-minutes)

Trial details

NCT IDNCT05125848

SponsorZynex Monitoring Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-04

Results submitted2023-12-15

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