Pilot Trial of the Robotic Uterine Manipulator
- Conditions
- Gynecologic Surgery
- Registration Number
- NCT03517228
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
- 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
- Female participant is not eligible if the surgeon does not plan to use a uterine manipulator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Consent only)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Consent only)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent only)🇺🇸Basking Ridge, New Jersey, United States