Blood LossNCT01846195
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw
A study testing CM 1500 in people with Blood Loss, run by Zynex Monitoring Solutions at 1 site in United States.
Trial summary
Non-invasive monitoring to measure changes in blood volume. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- CM 1500
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2012to 20 Mar 2013
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Between 18-35 years of age
- Weight between 130-200 pounds
Who cannot join
- Known cardiac disease
- Recent caffeine intake
- Tobacco use in the (4) hours prior to screening
- Infection
- Pregnancy
- Hemoglobin <13.5 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw
Non-invasive monitoring to measure changes in blood volume.
- Conditions
- Blood Loss
- Being tested
- CM 1500
- Keywords
- blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM 1500Device
| Study group | Role | What they receive |
|---|---|---|
| no blood draw | Sham comparator | CM 1500 with no blood draw Receives: Device: CM 1500 |
| blood draw | Active comparator | CM 1500 with blood draw Receives: Device: CM 1500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw
Measured: At study completion (completion of blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start6 Jun 2012
- Primary completion20 Mar 2013
- Study completion20 Mar 2013
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 Blood 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Monitoring Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DTarget
- Responsible party
- Sponsor
- Investigators
- John Ziegler, MD, Principal investigator, Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846195
- Sponsor's protocol ID
- Zynex500
- Status last verified
- Oct 2022
- First submitted
- 13 Mar 2013
- Last updated
- 9 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw
- ClinicalTrials.gov ID
- NCT01846195
- Acronym / sponsor ID
- Zynex500
- Conditions
- Blood Loss
- Keywords
- blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- DTarget
- Study start
- 6 Jun 2012 (actual)
- Primary completion
- 20 Mar 2013 (actual)
- Study completion
- 20 Mar 2013 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 9 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive monitoring to measure changes in blood volume.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no blood draw | Sham comparator | Device: CM 1500CM 1500 with no blood draw |
| blood draw | Active comparator | Device: CM 1500CM 1500 with blood draw |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Between 18-35 years of age
- Weight between 130-200 pounds
Key exclusion criteria (6 listed)
- Known cardiac disease
- Recent caffeine intake
- Tobacco use in the (4) hours prior to screening
- Infection
- Pregnancy
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 1500 | Device | blood draw, no blood draw |
Primary outcome
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Time frame: At study completion (completion of blood draw)
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Ziegler, MD principal investigator
Premier Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM 1500 in people with Blood Loss, run by Zynex Monitoring Solutions at 1 site 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 3 inclusion and 6 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 9 Nov 2022). 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?
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw (time frame: At study completion (completion of blood draw)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.