- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923544
Trial of YUMI Uterine Manipulator
May 3, 2022 updated by: Memorial Sloan Kettering Cancer Center
Pilot 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
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Middletown, New Jersey, United States, 07748
- Memoral Sloan Kettering Monmouth (Consent and Follow-Up only)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Consent and follow-up only)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (Consent and follow-up only)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Consent and follow-up only)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: total laparoscopic or robotic-assisted hysterectomy
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.
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yukio Sonoda, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2016
Primary Completion (Actual)
May 3, 2022
Study Completion (Actual)
May 3, 2022
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 16-1397
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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