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

• Sponsor: Zynex Monitoring Solutions (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05463198
• Collaborator: (none)
• Enrollment: 227
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 4
• Patients Per Site: 113.5
• Patients Per Site Per Month: 28.6

Study Details

Study Description

Brief Summary

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 227 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.

Condition or Disease	Intervention/Treatment	Phase
Fluid Loss	Device: CM-1600	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 227 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blood Loss	Device: CM-1600; Subjects undergoing blood donation will be connected to the CM-1600 device.

Outcome Measures

Primary Outcome Measures

1. Specificity and sensitivity of minor blood loss detection [15 - 60 minutes]

   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

1. Right vs left antecubital blood donation [15 - 60 minutes]

   Characterize the differences in the relative changes in right vs left antecubital blood donations

2. Correlation between physiological parameters and relative index [15 - 60 minutes]

   Investigate any possible correlations between adverse events, subject demographics, changes in the Relative Index, and timing of when the events occurred

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitalant Research Institute	Denver	Colorado	United States	80230
2	ClinCept, LLC	Columbus	Georgia	United States	31904

Sponsors and Collaborators

• Zynex Monitoring Solutions

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Zynex Monitoring Solutions
• ClinicalTrials.gov Identifier: NCT05463198
• Other Study ID Numbers: ZMS-1600-Blood Loss Detection
• First Posted: Jul 18, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Jul 18, 2022