Trial of YUMI Uterine Manipulator

Not Applicable

Completed

• Conditions: Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy; Gynecologic Condition
• Interventions: Procedure: YUMI manipulator

• Registration Number: NCT02923544
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test the feasibility and safety of using a new device called Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It is a reusable metal device designed to be simple and study. It is also adjustable in size which makes it easy for surgeons to use. It will be placed at the beginning of the surgery and removed at the end. This study will allow the researchers to find out if the surgeons find the YUMI effective and easy to use. It will also allow the researchers to see if the device is safe. This is the first time that the YUMI is being used in humans.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-27
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Status Verified: 2022-05
• Primary Completion: 2022-05-03
• Study Completion: 2022-05-03
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
• Participants must be 18 years of age or older

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Exclusion Criteria

• 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	YUMI manipulator	The YUMI manipulator will be placed at the start of each case. During the surgery, the surgeon will track any intraoperative complications. The surgeon fellow will also note the feasibility of placing the uterine manipulator.After surgery, the surgeon will complete the product evaluation form.

Primary Outcome Measures

Name	Time	Method
number of successfully placed Uterine Manipulator	1 year	The YUMI manipulator will be considered successfully placed when the device is inserted into the uterus and secured in place to hold for the duration of the procedure.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only); 🇺🇸 Basking Ridge, New Jersey, United States

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

Memorial Sloan Kettering Westchester (Consent and Follow-Up only); 🇺🇸 Harrison, New York, United States

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

Memoral Sloan Kettering Monmouth (Consent and Follow-Up only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Consent and Follow-Up only); 🇺🇸 Commack, New York, United States

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