Pilot Trial of the Robotic Uterine Manipulator

NATerminatedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

December 12, 2023

Study Completion Date

December 12, 2023

Conditions
Gynecologic Surgery
Interventions
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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Consent only), Harrison

11553

Memorial Sloan Kettering Nassau (Consent only), Uniondale

11725

Memorial Sloan Kettering Commack (Consent only), Commack

07920

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Consent only), Middletown

07645

Memorial Sloan Kettering Bergen (Consent only), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Northwell Health

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER