NCT03517228

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 7, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

5.6 years

First QC Date

April 24, 2018

Results QC Date

July 15, 2024

Last Update Submit

August 9, 2024

Conditions

Gynecologic Surgery

Keywords

Robotic Uterine Manipulator18-173

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

total laparoscopic or robotic-assisted hysterectomy

EXPERIMENTAL

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

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.

total laparoscopic or robotic-assisted hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgynecologic surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Female participant is not eligible if the surgeon does not plan to use a uterine manipulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

Results Point of Contact

Title
Dr. Mario Leitao, MD
Organization
Memorial Sloan Kettering Cancer Center
leitaom@mskcc.org
212-639-3987

Study Officials

  • Mario Leitao, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 7, 2018

Study Start

April 24, 2018

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

September 4, 2024

Results First Posted

August 7, 2024

Record last verified: 2024-08

Locations

US(7)