Back to resultsEvaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
Primary Purpose
Fluid Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CM-1600
Sponsored by
About this trial
This is an interventional diagnostic trial for Fluid Loss
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
Sites / Locations
- Vitalant Research Institute
- SunCoast Blood Centers
- ClinCept, LLC
- Blood Assurance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood Loss
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Right vs left antecubital blood donation
Characterize the differences in the relative changes in right vs left antecubital blood donations
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463198
Brief Title
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
Official Title
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
May 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zynex Monitoring Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Loss
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood Loss
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CM-1600
Intervention Description
Subjects undergoing blood donation will be connected to the CM-1600 device.
Primary Outcome Measure Information:
Title
Specificity and sensitivity of minor blood loss detection
Description
To determine the specificity and sensitivity of the CM-1600 Device in detecting minor blood loss as compared to standard physiological parameters
Time Frame
15 - 60 minutes
Secondary Outcome Measure Information:
Title
Right vs left antecubital blood donation
Description
Characterize the differences in the relative changes in right vs left antecubital blood donations
Time Frame
15 - 60 minutes
Title
Correlation between physiological parameters and relative index
Description
Investigate any possible correlations between adverse events, subject demographics, changes in the Relative Index, and timing of when the events occurred
Time Frame
15 - 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Vitalant Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
SunCoast Blood Centers
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
ClinCept, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Blood Assurance
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.zynexmonitoring.com
Description
Related Info
Learn more about this trial
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
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