Trial Outcomes & Findings for EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery (NCT NCT03319407)
NCT ID: NCT03319407
Last Updated: 2023-04-12
Results Overview
Recording of somatosensory evoked potential in patients undergoing genitourinary surgery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
in the first 24 hours of postoperative period
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Observation
All participants will be monitored with EPAD system
EPAD monitoring system: EPAD system will be used as part of routine care
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery
Baseline characteristics by cohort
| Measure |
Observation
n=21 Participants
All participants will be monitored with EPAD system
EPAD monitoring system: EPAD system will be used as part of routine care
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: in the first 24 hours of postoperative periodPopulation: Study terminated prematurely. Data was not collected.
Recording of somatosensory evoked potential in patients undergoing genitourinary surgery
Outcome measures
Outcome data not reported
Adverse Events
Observation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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