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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total laparoscopic or robotic-assisted hysterectomy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YUMI manipulator | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yukio Sonoda, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| 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 |