Clinical Evaluation of the CM-1500 During Hemodialysis

NCT05125848 | Completed Results FDA Device

• 1 other identifier: ZMS-1500-2021-Dialysis
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Loss; Dialysis

Outcome Measures

Primary Outcomes (1)

• Average Relative Index Value Following a Hemodialysis Procedure

  The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.

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

Secondary Outcomes (2)

• Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions

  Duration of standard dialysis procedure (Range: 131 to 241 minutes)

• Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions

  Duration of standard dialysis procedure (Range: 131 to 241 minutes)

Study Arms (1)

Hemodialysis Single Group Assignment

EXPERIMENTAL

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

Device: CM-1500

Interventions

CM-1500 DEVICE

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.

Hemodialysis Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Results Point of Contact

• Title: ZMS Clinical
• Organization: Zynex Monitoring Solutions

clinical@zynexmonitoring.com

(800) 495-6670

Study Officials

• Jonathan Tolins, MD

  InterMed Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: November 29, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Locations

US (1)