Pilot Trial of the Robotic Uterine Manipulator

Stopped early · Not applicable

Conditions studied: Gynecologic Surgery

In brief

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.

Key facts

Study ID

NCT03517228

Run by

Memorial Sloan Kettering Cancer Center

People needed

28

Starts

2018-04-24

Expected to finish

2023-12-12

Last updated by the study team

2024-09-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Female participant is not eligible if the surgeon does not plan to use a uterine manipulator

Where it is running

• 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

Full record on ClinicalTrials.gov

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