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Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

NCT05980013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-02

Study results available
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Summary

The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.

Conditions

  • Fluid Loss
  • Blood Loss

Interventions

DEVICE

Whole blood donation supine

Subjects will undergo a 1-unit whole blood donation in a supine position

DEVICE

Whole blood donation reclined

Subjects will undergo a 1-unit whole blood donation in a reclined position

Sponsors & Collaborators

  • Zynex Monitoring Solutions

    lead INDUSTRY

Principal Investigators

  • Debra Smith, MD; PhD · SunCoast Blood Centers

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-04-10
Completion
2024-04-10
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05980013 on ClinicalTrials.gov