MedTrace Logo

Clinical Evaluation of the CM-1500 During Hemodialysis

NCT05125848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-05-01

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Zynex Monitoring Solutions

    lead INDUSTRY

Principal Investigators

  • Jonathan Tolins, MD · InterMed Consultants

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-03-04
Completion
2022-03-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125848 on ClinicalTrials.gov