Pilot Trial of the Robotic Uterine Manipulator

Not Applicable

Completed

• Conditions: Gynecologic Surgery
• Interventions: Device: BAUM device

• Registration Number: NCT03517228
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-07
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Status Verified: 2024-07
• Results First Submitted: 2024-07-15
• Results First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Results First Posted: 2024-08-07
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
total laparoscopic or robotic-assisted hysterectomy	BAUM device	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.

Primary Outcome Measures

Name	Time	Method
the Number of Intraoperative Complications Attributed to the Robotic Manipulator.	25- 35 days	will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, 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 Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States