Trial Outcomes & Findings for Pilot Trial of the Robotic Uterine Manipulator (NCT NCT03517228)
NCT ID: NCT03517228
Last Updated: 2024-09-04
Results Overview
will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
25- 35 days
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Total Laparoscopic or Robotic-assisted Hysterectomy
All patients who are consented for a total laparoscopic or robotic-assisted hysterectomy will be eligible for the trial, unless the surgeon does not plan to use a uterine manipulator.
BAUM device: The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Total Laparoscopic or Robotic-assisted Hysterectomy
All patients who are consented for a total laparoscopic or robotic-assisted hysterectomy will be eligible for the trial, unless the surgeon does not plan to use a uterine manipulator.
BAUM device: The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Hard drive issues, abandoned prior to surgery
|
2
|
|
Overall Study
Anatomy issue - abandoned prior to surgery
|
1
|
|
Overall Study
Surgery was at MAIN, could not change location to JOSIE
|
1
|
|
Overall Study
Canceled due to device being updated
|
1
|
|
Overall Study
No V Cares in stock
|
1
|
|
Overall Study
Service issue, use of device cancelled prior to surgery
|
2
|
Baseline Characteristics
Pilot Trial of the Robotic Uterine Manipulator
Baseline characteristics by cohort
| Measure |
Total Laparoscopic or Robotic-assisted Hysterectomy
n=28 Participants
All patients who are consented for a total laparoscopic or robotic-assisted hysterectomy will be eligible for the trial, unless the surgeon does not plan to use a uterine manipulator.
BAUM device: The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.
|
|---|---|
|
Age, Continuous
|
57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 25- 35 dayswill be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
Outcome measures
| Measure |
Total Laparoscopic or Robotic-assisted Hysterectomy
n=28 Participants
All patients who are consented for a total laparoscopic or robotic-assisted hysterectomy will be eligible for the trial, unless the surgeon does not plan to use a uterine manipulator.
BAUM device: The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.
|
|---|---|
|
the Number of Intraoperative Complications Attributed to the Robotic Manipulator.
|
0 # of intraoperative complications
|
Adverse Events
Total Laparoscopic or Robotic-assisted Hysterectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mario Leitao, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3987
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place