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Trial of YUMI Uterine Manipulator

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02923544
Collaborator
(none)
11
Enrollment
7
Locations
1
Arm
67.2
Actual Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: YUMI manipulator
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial of YUMI Uterine Manipulator
Actual Study Start Date :
Sep 27, 2016
Actual Primary Completion Date :
May 3, 2022
Actual Study Completion Date :
May 3, 2022

Arms and Interventions

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.

Procedure: YUMI manipulator
Other Names:
  • Yukio's Uterine Manipulating Instrument

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) Basking Ridge New Jersey United States 07920
    2 Memoral Sloan Kettering Monmouth (Consent and Follow-Up only) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (Consent and Follow-Up only) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Commack (Consent and Follow-Up only) Commack New York United States 11725
    5 Memorial Sloan Kettering Westchester (Consent and Follow-Up only) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Memorial Sloan Kettering Nassau (Consent and Follow-Up only) Uniondale New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Yukio Sonoda, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02923544
    Other Study ID Numbers:
    • 16-1397
    First Posted:
    Oct 4, 2016
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Uterine Manipulator
    Yukio's Uterine Manipulating Instrument (YUMI)
    16-1397

    Study Results

    No Results Posted as of May 4, 2022