Trial of YUMI Uterine Manipulator

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

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

Treatments: Procedure: YUMI manipulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02923544

16-1397

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

total laparoscopic or robotic-assisted hysterectomy

Experimental group

Description:

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.

Treatment:

Procedure: YUMI manipulator