Fluid LossNCT05125848
Clinical Evaluation of the CM-1500 During Hemodialysis
A study testing CM-1500 in people with Fluid Loss and Dialysis, 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 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Loss, Dialysis
- What is being tested?
- CM-1500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 4 Mar 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
- No healthy volunteers
- 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, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session
- 18 years of age or older
- Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.
Who cannot join
- Females who are pregnant or breastfeeding
- Undergone an amputation of the left upper extremity
- Subjects with left arm hemodialysis access only
- Diagnosed with dextrocardia
- Subjects who have a pacemaker
- Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
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 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.
- Conditions
- Fluid Loss, Dialysis
- Being tested
- CM-1500
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. This value is indicative of relative changes in fluid volume.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Single Group Assignment | Experimental | All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session Receives: Device: CM-1500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Relative Index Value Following a Hemodialysis Procedure
The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. 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. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.
Measured: Duration of post-hemodialysis recovery period (10-minutes)
Secondary outcomes (2)
Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
The secondary objective is to characterize intrasubject variability in RI changes across 3 hemodialysis sessions. Cohort intrasubject variability was calculated by averaging individual subject standard deviations across enrollments. Variability for each subject is calculated by finding the RI mean and standard deviation for all RI values (1 per sec) during all 3 monitoring sessions. 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 min. or max. 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: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
The secondary objective is to characterize intersubject variability in RI changes across 3 hemodialysis sessions. Intersubject variability was calculated by finding the mean and standard deviation of the variability (standard deviation) from the mean RI values (1 value per sec) for each hemodialysis session monitoring period (3 sessions x 15 subjects = 45 individual monitoring sessions). 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 min. or max., 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: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start29 Nov 2021
- Primary completion4 Mar 2022
- Study completion4 Mar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Monitoring Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tolins, MD, Principal investigator, InterMed Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125848
- Sponsor's protocol ID
- ZMS-1500-2021-Dialysis
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2021
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the CM-1500 During Hemodialysis
- ClinicalTrials.gov ID
- NCT05125848
- Acronym / sponsor ID
- ZMS-1500-2021-Dialysis
- Conditions
- Fluid Loss, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Posted 1 May 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 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Single Group Assignment | Experimental | Device: CM-1500All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session
- 18 years of age or older
- Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.
Key exclusion criteria (6 listed)
- Females who are pregnant or breastfeeding
- Undergone an amputation of the left upper extremity
- Subjects with left arm hemodialysis access only
- 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. This value is indicative of relative changes in fluid volume. | Device | Hemodialysis Single Group Assignment |
Primary outcome
Average Relative Index Value Following a Hemodialysis Procedure
Time frame: Duration of post-hemodialysis recovery period (10-minutes)
The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. 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. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.
2 secondary outcomes
Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
Time frame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
Time frame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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.
Jonathan Tolins, MD principal investigator
InterMed Consultants
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 Fluid Loss and Dialysis, 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 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 1 May 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 1 May 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?
Average Relative Index Value Following a Hemodialysis Procedure (time frame: Duration of post-hemodialysis recovery period (10-minutes)). 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 1 May 2024.