Fluid LossNCT05463198

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

A study testing CM-1600 in people with Fluid Loss, run by Zynex Monitoring Solutions at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Fluid Loss
What is being tested?: CM-1600
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 4 sitesUnited States
Study dates: 14 Sep 2022to 26 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

SunCoast Blood Centers
Bradenton, Florida, 34211
Blood Assurance
Chattanooga, Tennessee, 37403
ClinCept, LLC
Columbus, Georgia, 31904
Vitalant Research Institute
Denver, Colorado, 80230

Other trials in United States

About this study

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.

Conditions: Fluid Loss
Being tested: CM-1600

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05463198
Study group	Role	What they receive
Blood Loss	Experimental	Not described Receives: Device: CM-1600

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)
The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
Measured: Recovery period following donation (10 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202226 May 2023

First posted18 Jul 2022
Study start14 Sep 2022
Primary completion27 Apr 2023
Study completion26 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fluid LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05463198
Sponsor's protocol ID: ZMS-1600-Blood Loss Detection
Status last verified: Jul 2024
First submitted: 14 Jul 2022
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
RecruitingObservational study
Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
Periodontal Diseases, Periimplant Diseases
Active, not recruitingPhase 1
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Alzheimer Disease, Mild Cognitive Impairment
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
Not yet recruitingPhase 1/2
XVIE to Treat Androgenetic Alopecia (AGA)
Androgenetic Alopecia

All Fluid Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
ClinicalTrials.gov ID: NCT05463198
Acronym / sponsor ID: ZMS-1600-Blood Loss Detection
Conditions: Fluid Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
Study start: 14 Sep 2022 (actual)
Primary completion: 27 Apr 2023 (actual)
Study completion: 26 May 2023 (actual)
First posted: 18 Jul 2022 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blood Loss	Experimental	Device: CM-1600

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CM-1600Subjects undergoing blood donation will be connected to the CM-1600 device.	Device	Blood Loss

Primary outcome

Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)
Time frame: Recovery period following donation (10 minutes)
The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blood Loss	351	314

Primary outcome: Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)

Time frame: Recovery period following donation (10 minutes). Mean (Standard Deviation). Unit: Percent change in RI

Measure	Blood Loss n = 314
Value	2.9 (151.1)

Population analysed: 18 subjects were unevaluable; 19 subjects were withdrawn

Adverse events

Time frame: Adverse Events were recorded during subject participation and for 24hrs after participation was complete, a total of up to 27hrs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blood Loss	0 of 351 (0%)	4 of 351 (1.1%)	0 of 351

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Fluid Loss

Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
RecruitingObservational study
Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
Periodontal Diseases, Periimplant Diseases
Active, not recruitingPhase 1
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Alzheimer Disease, Mild Cognitive Impairment
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
Not yet recruitingPhase 1/2
XVIE to Treat Androgenetic Alopecia (AGA)
Androgenetic Alopecia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CM-1600 in people with Fluid Loss, run by Zynex Monitoring Solutions at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) (time frame: Recovery period following donation (10 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.