Clinical Evaluation of the CM-1500 During Hemodialysis

Dialysis Clinical Trial

Official title:

Clinical Evaluation of the CM-1500 During Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125848
• Other study ID #: ZMS-1500-2021-Dialysis
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: May 2022
• Source: Zynex Monitoring Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Fluid Loss

Intervention

Device:
• CM-1500
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume.

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Zynex Monitoring Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize changes in the Relative Index During a Hemodialysis Procedure	The primary objective of the study is to characterize changes in the CM-1500 Relative Index over the duration of a hemodialysis procedure	1-6 hours
Secondary	Characterize the intersubject and intrasubject variability in Relative Index changes across multiple hemodialysis sessions	The secondary objective of the study is to characterize the intersubject and intrasubject variability in Relative Index changes across the three hemodialysis sessions	1-2 weeks