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NCT03517228 Clinical Trial

Pilot Trial of the Robotic Uterine Manipulator

Gynecologic Surgery Clinical Trial

Official title:
Pilot Trial of the Robotic Uterine Manipulator

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03517228
Other study ID # 18-173
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2018
Est. completion date December 12, 2023

Study information
Verified date December 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 12, 2023
Est. primary completion date December 12, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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