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Pilot Trial of the Robotic Uterine Manipulator

NCT03517228 · Memorial Sloan Kettering Cancer Center · Updated 4 Sept 2024

What is being tested
BAUM device
For
Gynecologic Surgery
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 28 people. The full rules are on the registry page.
Where
United States (7 sites)
When
Starts or started 24 April 2018, ends 12 Dec 2023. Registered 7 May 2018.
Results
Posted on the registry on 7 Aug 2024.

In the researchers' words

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.
ClinicalTrials.gov, NCT03517228

Sites

  • 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 CenterNew York, New York, United States
  • Memorial Sloan Kettering Nassau (Consent only)Uniondale, New York, United States