Trial Outcomes & Findings for Clinical Evaluation of the CM-1500 During Apheresis Blood Donation (NCT NCT05012462)
NCT ID: NCT05012462
Last Updated: 2024-12-06
Results Overview
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.
COMPLETED
NA
77 participants
Duration of apheresis procedure (e.g., 2 - 3hrs)
2024-12-06
Participant Flow
Participant milestones
| Measure |
Apheresis Platelet Donation: CM-1500
The subjects will be connected to the CM-1500 during apheresis platelet donation
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.
|
Apheresis Platelet Donation: CM-1600
The subjects will be connected to the CM-1600 during apheresis platelet donation
CM-1600: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
31
|
|
Overall Study
COMPLETED
|
42
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Apheresis Platelet Donation: CM-1500
n=46 Participants
The subjects will be connected to the CM-1500 during apheresis platelet donation
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.
|
Apheresis Platelet Donation: CM-1600
n=31 Participants
The subjects will be connected to the CM-1600 during apheresis platelet donation
CM-1600: 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.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
47.3 years
STANDARD_DEVIATION 17.2 • n=46 Participants
|
58.7 years
STANDARD_DEVIATION 12.5 • n=31 Participants
|
50.7 years
STANDARD_DEVIATION 16.5 • n=77 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=46 Participants
|
15 Participants
n=31 Participants
|
40 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=46 Participants
|
16 Participants
n=31 Participants
|
37 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
31 participants
n=31 Participants
|
77 participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Duration of apheresis procedure (e.g., 2 - 3hrs)Population: 4 subjects were withdrawn from the CM-1500 Arm, and 3 subjects were withdrawn from the CM-1600 Arm
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.
Outcome measures
| Measure |
Apheresis Platelet Donation: CM-1500
n=42 Participants
The subjects will be connected to the CM-1500 during apheresis platelet donation
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.
|
Apheresis Platelet Donation: CM-1600
n=28 Participants
The subjects will be connected to the CM-1600 during apheresis platelet donation
CM-1600: 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.
|
|---|---|---|
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Characterize Changes in the Relative Index During an Apheresis Procedure
|
94.9 Relative Index
Standard Deviation 5.6
|
99.3 Relative Index
Standard Deviation 26.3
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Adverse Events
Apheresis Platelet Donation: CM-1500
Apheresis Platelet Donation: CM-1600
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apheresis Platelet Donation: CM-1500
n=46 participants at risk
The subjects will be connected to the CM-1500 during apheresis platelet donation
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.
|
Apheresis Platelet Donation: CM-1600
n=31 participants at risk
The subjects will be connected to the CM-1600 during apheresis platelet donation
CM-1600: 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.
|
|---|---|---|
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Skin and subcutaneous tissue disorders
Skin Irritation
|
2.2%
1/46 • Number of events 1 • Adverse Event data were collected during subject participation and for 24hrs following, a total of up to 29hrs.
|
3.2%
1/31 • Number of events 1 • Adverse Event data were collected during subject participation and for 24hrs following, a total of up to 29hrs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place