Gynecologic Condition, Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy
Conditions
Keywords
Uterine Manipulator, Yukio's Uterine Manipulating Instrument (YUMI), 16-1397
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.
Interventions
PROCEDUREYUMI manipulator
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed