Trial of YUMI Uterine Manipulator
Pilot Trial of YUMI Uterine Manipulator
1 other identifier
interventional
11
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedMay 4, 2022
May 1, 2022
5.6 years
October 3, 2016
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of successfully placed Uterine Manipulator
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.
1 year
Study Arms (1)
total laparoscopic or robotic-assisted hysterectomy
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth (Consent and Follow-Up only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent and Follow-Up only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
Uniondale, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Yukio Sonoda, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 4, 2016
Study Start
September 27, 2016
Primary Completion
May 3, 2022
Study Completion
May 3, 2022
Last Updated
May 4, 2022
Record last verified: 2022-05