Completed

NCT Number: NCT02923544

Trial of YUMI Uterine Manipulator

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.

Completed

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Key information

Conditions

Gynecologic Condition Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

YUMI manipulator

Procedure

Other names: Yukio's Uterine Manipulating Instrument

Primary outcomes

number of successfully placed Uterine Manipulator

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Pilot Trial of YUMI Uterine Manipulator

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Oct 4, 2016
Registry last updated: May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.