Trial of YUMI Uterine Manipulator

Completed · Not applicable

Conditions studied: Gynecologic Condition, Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy

In brief

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.

Key facts

Study ID

NCT02923544

Run by

Memorial Sloan Kettering Cancer Center

People needed

11

Starts

2016-09-27

Expected to finish

2022-05-03

Last updated by the study team

2022-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) — Basking Ridge, New Jersey, United States
• Memoral Sloan Kettering Monmouth (Consent and Follow-Up only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent and Follow-Up only) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent and Follow-Up only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent and Follow-Up only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and Follow-Up only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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