Pilot Trial of the Robotic Uterine Manipulator

Memorial Sloan Kettering Cancer Center28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gynecologic Surgery

Interventions

BAUM deviceDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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)

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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