Gynecologic Surgery
Conditions
Keywords
Robotic Uterine Manipulator, 18-173
Brief summary
The purpose of this study is to test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.
Interventions
DEVICEBAUM 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.
Sponsors
Northwell Health
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition * Female participants must be 18 years of age or older
Exclusion criteria
* Female participant is not eligible if the surgeon does not plan to use a uterine manipulator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Number of Intraoperative Complications Attributed to the Robotic Manipulator. | 25- 35 days | will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Anatomy issue - abandoned prior to surgery | 1 |
| Overall Study | Canceled due to device being updated | 1 |
| Overall Study | Hard drive issues, abandoned prior to surgery | 2 |
| Overall Study | No V Cares in stock | 1 |
| Overall Study | Service issue, use of device cancelled prior to surgery | 2 |
| Overall Study | Surgery was at MAIN, could not change location to JOSIE | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Total Laparoscopic or Robotic-assisted Hysterectomy |
|---|---|
| Age, Continuous | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
the Number of Intraoperative Complications Attributed to the Robotic Manipulator.
will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
Time frame: 25- 35 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Laparoscopic or Robotic-assisted Hysterectomy | the Number of Intraoperative Complications Attributed to the Robotic Manipulator. | 0 # of intraoperative complications |