Pilot Trial of the Robotic Uterine Manipulator

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 Overview

• Status: Completed
• Conditions: Gynecologic Surgery
• Intervention / Treatment: Device: BAUM device

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Consent Only)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent Only)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent only)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: total laparoscopic or robotic-assisted hysterectomy; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	25- 35 days

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Mario Leitao, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Robotic Uterine Manipulator; 18-173
• Other Study ID Numbers: 18-173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No