Trial Outcomes & Findings for Clinical Evaluation of the CM-1500 During Hemodialysis (NCT NCT05125848)
NCT ID: NCT05125848
Last Updated: 2024-05-01
Results Overview
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.
COMPLETED
NA
15 participants
Duration of post-hemodialysis recovery period (10-minutes)
2024-05-01
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hemodialysis Single Group Assignment
n=15 Participants
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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Age, Continuous
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52.2 years
STANDARD_DEVIATION 16.1 • n=15 Participants
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Sex: Female, Male
Female
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7 Participants
n=15 Participants
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Sex: Female, Male
Male
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8 Participants
n=15 Participants
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Region of Enrollment
United States
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15 participants
n=15 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hemodialysis Single Group Assignment
n=15 Participants
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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Average Relative Index Value Following a Hemodialysis Procedure
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93.05 Relative Index (RI)
Standard Deviation 0.43
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SECONDARY outcome
Timeframe: Duration of standard dialysis procedure (Range: 131 to 241 minutes)Population: Each subject was monitored for 3 separate hemodialysis sessions. Intrasubject variability was determined by comparing the 3 sessions for each subject against each other.
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.
Outcome measures
| Measure |
Hemodialysis Single Group Assignment
n=15 Participants
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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Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
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2.27 Relative Index (RI)
Standard Deviation 2.07
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SECONDARY outcome
Timeframe: Duration of standard dialysis procedure (Range: 131 to 241 minutes)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.
Outcome measures
| Measure |
Hemodialysis Single Group Assignment
n=15 Participants
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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Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
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2.91 Relative Index (RI)
Standard Deviation 3.27
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Adverse Events
Hemodialysis Single Group Assignment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hemodialysis Single Group Assignment
n=15 participants at risk
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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Skin and subcutaneous tissue disorders
Minor Adverse Event
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6.7%
1/15 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place