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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis Single Group Assignment | Experimental | All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM-1500 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of post-hemodialysis recovery period (10-minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Tolins, MD | InterMed Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemodialysis Single Group Assignment | All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session CM-1500: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemodialysis Single Group Assignment | All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session CM-1500: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Relative Index (RI) | Duration of post-hemodialysis recovery period (10-minutes) |
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Adverse event data were collected during subject participation and for 48hrs following the completion of subject participation, up to 17 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemodialysis Single Group Assignment | All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session CM-1500: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Adverse Event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject experienced minor skin irritation/redness after electrode removal. Symptoms resolved without treatment and was designated as Not Serious by the Investigator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ZMS Clinical | Zynex Monitoring Solutions | (800) 495-6670 | clinical@zynexmonitoring.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2021 | Dec 15, 2023 | Prot_SAP_000.pdf |
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| 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. | Duration of standard dialysis procedure (Range: 131 to 241 minutes) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Hemodialysis Single Group Assignment |
All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session CM-1500: 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. |
|
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| Secondary | 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. | Each subject was monitored for 3 separate hemodialysis sessions. Intrasubject variability was determined by comparing the 3 sessions for each subject against each other. | Posted | Mean | Standard Deviation | Relative Index (RI) | Duration of standard dialysis procedure (Range: 131 to 241 minutes) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Relative Index (RI) | Duration of standard dialysis procedure (Range: 131 to 241 minutes) |
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| 0 |
| 15 |
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| 15 |
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