Fluid LossNCT05012462
Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
A study testing CM-1500 and CM-1600 in people with Fluid Loss, run by Zynex Monitoring Solutions at 1 site in United States.
Trial summary
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Read more about this study
- 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-1500 and CM-1600
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 20 Dec 2022
- 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 informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- 18 years of age or older
- Consented to undergo an apheresis procedure with an automated blood component device
Who cannot join
- Females who are pregnant or breastfeeding
- Undergone an amputation of the left upper extremity
- Diagnosed with dextrocardia
- Subjects who have a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.
- Conditions
- Fluid Loss
- Being tested
- CM-1500, CM-1600
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-1500Device
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.
CM-1600Device
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.
| Study group | Role | What they receive |
|---|---|---|
| Apheresis Platelet Donation: CM-1500 | Experimental | The subjects will be connected to the CM-1500 during apheresis platelet donation Receives: Device: CM-1500 |
| Apheresis Platelet Donation: CM-1600 | Experimental | The subjects will be connected to the CM-1600 during apheresis platelet donation Receives: Device: CM-1600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Changes in the Relative Index During an Apheresis Procedure
The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.
Measured: Duration of apheresis procedure (e.g., 2 - 3hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start20 Sep 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Monitoring Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samantha Mack, MD, Principal investigator, Vitalant Blood Donation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012462
- Sponsor's protocol ID
- ZMS-1500-2021-Apheresis
- Status last verified
- Dec 2024
- First submitted
- 6 Aug 2021
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
- ClinicalTrials.gov ID
- NCT05012462
- Acronym / sponsor ID
- ZMS-1500-2021-Apheresis
- Conditions
- Fluid Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apheresis Platelet Donation: CM-1500 | Experimental | Device: CM-1500The subjects will be connected to the CM-1500 during apheresis platelet donation |
| Apheresis Platelet Donation: CM-1600 | Experimental | Device: CM-1600The subjects will be connected to the CM-1600 during apheresis platelet donation |
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 informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- 18 years of age or older
- Consented to undergo an apheresis procedure with an automated blood component device
Key exclusion criteria (4 listed)
- Females who are pregnant or breastfeeding
- Undergone an amputation of the left upper extremity
- Diagnosed with dextrocardia
- Subjects who have a pacemaker
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-1500The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. | Device | Apheresis Platelet Donation: CM-1500 |
| CM-1600The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value. | Device | Apheresis Platelet Donation: CM-1600 |
Primary outcome
Characterize Changes in the Relative Index During an Apheresis Procedure
Time frame: Duration of apheresis procedure (e.g., 2 - 3hrs)
The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Samantha Mack, MD principal investigator
Vitalant Blood Donation
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 and CM-1600 in people with Fluid 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 4 inclusion and 4 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 6 Dec 2024. 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. 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 6 Dec 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?
Characterize Changes in the Relative Index During an Apheresis Procedure (time frame: Duration of apheresis procedure (e.g., 2 - 3hrs)). 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 6 Dec 2024.