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Enrollment incomplete
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total laparoscopic or robotic-assisted hysterectomy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAUM device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 25- 35 days |
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Inclusion Criteria:
Exclusion Criteria:
gynecologic surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mario Leitao, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | # of intraoperative complications | 25- 35 days |
|
Up to 35 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mario Leitao, MD | Memorial Sloan Kettering Cancer Center | 212-639-3987 | leitaom@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2022 | Jul 15, 2024 | Prot_SAP_000.pdf |
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|
| Memorial Sloan Kettering Monmouth (Consent only) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Consent only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent only) | Uniondale | New York | 11553 | United States |
| Surgery was at MAIN, could not change location to JOSIE |
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| Canceled due to device being updated |
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| No V Cares in stock |
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| Service issue, use of device cancelled prior to surgery |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 3 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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