N/A N=351 Diagnostic

Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

Fluid Loss

Bottom Line

View on ClinicalTrials.gov: NCT05463198 ↗

Enrolled (actual)

351

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) — 2.9 Percent change in RI

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CM-1600 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zynex Monitoring Solutions
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)	2.9	—

Summary

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

Eligibility Criteria

Inclusion Criteria

Ability to provide written consent
Ability and willingness to comply with the study procedures and duration requirements
18 years of age or older
Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria

Females who are pregnant or breastfeeding
Undergone an amputation of any upper extremity
Diagnosed with dextrocardia
Subjects who have a pacemaker
Subjects with body hair density which prevents adequate application of device electrodes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05463198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.