NCT03517228

Pilot Trial of the Robotic Uterine Manipulator

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Surgery

Interventions

Type	Name	Description
DEVICE	BAUM device	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.

Timeline

• Start date: 2018-04-24
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2018-05-07
• Last updated: 2024-09-04
• Results posted: 2024-08-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study