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Trial of YUMI Uterine Manipulator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923544
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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
Gynecologic Condition Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy Procedure: YUMI manipulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of YUMI Uterine Manipulator
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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 Name: Yukio's Uterine Manipulating Instrument




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923544


Contacts
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Contact: Yukio Sonoda, MD 212-639-6450
Contact: Nadeem Abu-Rustum, MD 212-639-7051

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Yukio Sonoda, MD    212-639-6450      
Memoral Sloan Kettering Monmouth (Consent and Follow-Up only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Yukio Sonoda, MD    212-639-6450      
Memorial Sloan Kettering Bergen (Consent and Follow-Up only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Yukio Sonoda, MD    212-639-6450      
United States, New York
Memorial Sloan Kettering Commack (Consent and Follow-Up only) Recruiting
Commack, New York, United States, 11725
Contact: Yukio Sonoda, MD    212-639-6450      
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Memorial Sloan Kettering Westchester (Consent and Follow-Up only) Recruiting
Harrison, New York, United States, 10604
Contact: Yukio Sonoda, MD    212-639-6450      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Yukio Sonoda, MD    212-639-6450      
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Principal Investigator: Yukio Sonoda         
Memorial Sloan Kettering Nassau (Consent and Follow-Up only) Recruiting
Uniondale, New York, United States, 11553
Contact: Yulio Sonoda, MD    212-639-6450      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Yukio Sonoda, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02923544    
Other Study ID Numbers: 16-1397
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Uterine Manipulator
Yukio's Uterine Manipulating Instrument (YUMI)
16-1397