Pilot Trial of the Robotic Uterine Manipulator

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Gynecologic Surgery

Treatments: Device: BAUM device

Study type: Interventional

Funder types: Other

Identifiers

NCT03517228

18-173

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

total laparoscopic or robotic-assisted hysterectomy

Experimental group

Description:

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.

Treatment:

Device: BAUM device