Blood LossPhase 1NCT01834612
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
A Phase 1 study testing CM1500 in people with Blood Loss, run by Zynex Monitoring Solutions at 1 site in United States.
Trial summary
To determine if a manual blood loss can be detected using the non-invasive blood monitor. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- CM1500
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2013to 11 Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
- between 18 to 50 years of age
- weight between 157 to 220 lbs
Who cannot join
- unstable or untreated cardia disease
- alcohol consumption in 24 hours prior to screening
- tobacco use in 4 hours prior to screening
- pregnancy
- infection
- Hemoglobin < 12.5 g/dL at time of procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
To determine if a manual blood loss can be detected using the non-invasive blood monitor.
- Conditions
- Blood Loss
- Being tested
- CM1500
- Keywords
- blood loss, hemorrhage, hemorrhagic shcok
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM1500Device
blood volume monitor
| Study group | Role | What they receive |
|---|---|---|
| Blood draw | Active comparator | CM1500 with blood draw Receives: Device: CM1500 |
| No blood draw | Sham comparator | CM 1500 with no blood draw Receives: Device: CM1500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect change in blood volume by non-invasive monitoring during whole blood draw
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study start7 Jan 2013
- Primary completion11 Mar 2013
- Study completion11 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Monitoring Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Galloway, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834612
- Sponsor's protocol ID
- Zynex 750
- Status last verified
- Jul 2021
- First submitted
- 15 Apr 2013
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
- ClinicalTrials.gov ID
- NCT01834612
- Acronym / sponsor ID
- Zynex 750
- Conditions
- Blood Loss
- Keywords
- blood loss, hemorrhage, hemorrhagic shcok
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 11 Mar 2013 (actual)
- Study completion
- 11 Mar 2013 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a manual blood loss can be detected using the non-invasive blood monitor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood draw | Active comparator | Device: CM1500CM1500 with blood draw |
| No blood draw | Sham comparator | Device: CM1500CM 1500 with no blood draw |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteer
- between 18 to 50 years of age
- weight between 157 to 220 lbs
Key exclusion criteria (6 listed)
- unstable or untreated cardia disease
- alcohol consumption in 24 hours prior to screening
- tobacco use in 4 hours prior to screening
- pregnancy
- infection
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 |
|---|---|---|
| CM1500blood volume monitor | Device | Blood draw, No blood draw |
Primary outcome
Detect change in blood volume by non-invasive monitoring during whole blood draw
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Chris Galloway, MD principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM1500 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 21 Jul 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change in blood volume by non-invasive monitoring during whole blood draw (time frame: 4 months). 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 21 Jul 2021.