Trial Outcomes & Findings for Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients (NCT NCT04706221)
NCT ID: NCT04706221
Last Updated: 2024-03-27
Results Overview
The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.
COMPLETED
NA
200 participants
Length of PACU Stay (Range: 46 to 353 minutes)
2024-03-27
Participant Flow
Participant milestones
| Measure |
Blood Volume Monitoring - Open Surgery
Monitoring with CM-1500 (Blood volume monitor CM-1500) during Open Surgery
|
Blood Volume Monitoring - Laparoscopic Surgery
Monitoring with CM-1500 (Blood volume monitor CM-1500) during Laparoscopic Surgery
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
109
|
|
Overall Study
COMPLETED
|
75
|
98
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Volume Monitoring Laparoscopic Surgery
n=98 Participants
CM-1500: Blood volume monitor post-laparoscopic surgery
|
Blood Volume Monitoring - Open Surgery
n=75 Participants
CM-1500: Blood volume monitor post-open surgery
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=98 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=173 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=98 Participants
|
45 Participants
n=75 Participants
|
115 Participants
n=173 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=98 Participants
|
30 Participants
n=75 Participants
|
58 Participants
n=173 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 14.3 • n=98 Participants
|
58.4 years
STANDARD_DEVIATION 15.2 • n=75 Participants
|
56.25 years
STANDARD_DEVIATION 14.7 • n=173 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=98 Participants
|
40 Participants
n=75 Participants
|
102 Participants
n=173 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=98 Participants
|
35 Participants
n=75 Participants
|
71 Participants
n=173 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
98 Participants
n=98 Participants
|
75 Participants
n=75 Participants
|
173 Participants
n=173 Participants
|
PRIMARY outcome
Timeframe: Length of PACU Stay (Range: 46 to 353 minutes)The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.
Outcome measures
| Measure |
Blood Volume Monitoring - Open Surgery
n=75 Participants
CM-1500: Monitoring with CM-1500 (Blood Volume Monitor CM-1500) during Open Surgery
|
Blood Volume Monitoring - Laparoscopic Surgery
n=98 Participants
CM-1500: Monitoring with CM-1500 (Blood Volume Monitor CM-1500) during Laparoscopic Surgery
|
|---|---|---|
|
Relative Index Change During PACU Stay
|
-2.01 Relative Index (RI)
Standard Deviation 4.00
|
-1.32 Relative Index (RI)
Standard Deviation 3.11
|
Adverse Events
Blood Volume Monitoring Laparoscopic Surgery
Blood Volume Monitoring - Open Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place