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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05980013

Fluid Loss Blood Loss

COMPLETED NA

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

NCT05012462

Fluid Loss

COMPLETED NA

Clinical Evaluation of the Zynex Monitoring System, Model CM-1600

NCT05740644

Fluid Loss

COMPLETED NA

Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

NCT01834612

Blood Loss

COMPLETED PHASE1

Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

NCT01846195

Blood Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood Loss

Group Type EXPERIMENTAL

CM-1600

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CM-1600

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes