CM-1600 for Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vitalant Research Institute, Denver, CO
Hemorrhage+1 More
CM-1600 - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Hemorrhage
  • Fluid Loss

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 15 - 60 minutes

15 - 60 minutes
Correlation between physiological parameters and relative index
Right vs left antecubital blood donation
Specificity and sensitivity of minor blood loss detection

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Blood Loss
1 of 1
Experimental Treatment

227 Total Participants · 1 Treatment Group

Primary Treatment: CM-1600 · No Placebo Group · N/A

Blood Loss
Device
Experimental Group · 1 Intervention: CM-1600 · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 - 60 minutes
Closest Location: Vitalant Research Institute · Denver, CO
Photo of Denver 1Photo of Denver 2Photo of Denver 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Hemorrhage
0 CompletedClinical Trials

Who is running the clinical trial?

Zynex Monitoring SolutionsLead Sponsor
6 Previous Clinical Trials
505 Total Patients Enrolled
4 Trials studying Hemorrhage
290 Patients Enrolled for Hemorrhage

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the test if you are at least 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.