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NCT05463198 Clinical Trial

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

Fluid Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05463198
Other study ID # ZMS-1600-Blood Loss Detection
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date May 26, 2023

Study information
Verified date May 2023
Source Zynex Monitoring Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 351
Est. completion date May 26, 2023
Est. primary completion date April 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CM-1600
Subjects undergoing blood donation will be connected to the CM-1600 device.

Locations
Country Name City State
United States SunCoast Blood Centers Bradenton Florida
United States Blood Assurance Chattanooga Tennessee
United States ClinCept, LLC Columbus Georgia
United States Vitalant Research Institute Denver Colorado

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 Specificity and sensitivity of minor blood loss detection To determine the specificity and sensitivity of the CM-1600 Device in detecting minor blood loss as compared to standard physiological parameters 15 - 60 minutes
Secondary Right vs left antecubital blood donation Characterize the differences in the relative changes in right vs left antecubital blood donations 15 - 60 minutes
Secondary Correlation between physiological parameters and relative index Investigate any possible correlations between adverse events, subject demographics, changes in the Relative Index, and timing of when the events occurred 15 - 60 minutes
See also
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