Gynecologic ConditionNCT02923544
Trial of YUMI Uterine Manipulator
A study testing YUMI manipulator in people with Gynecologic Condition and Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Condition, Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy
- What is being tested?
- YUMI manipulator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Sep 2016to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant is not eligible if the surgeon does not plan to use a uterine manipulator
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and Follow-Up only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (Consent and Follow-Up only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
Uniondale, New York, 11553
About this study
Official title: 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.
- Conditions
- Gynecologic Condition, Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy
- Being tested
- YUMI manipulator
- Keywords
- Uterine Manipulator, Yukio's Uterine Manipulating Instrument (YUMI), 16-1397
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YUMI manipulatorProcedure or surgery
Also called Yukio's Uterine Manipulating Instrument
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: YUMI manipulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start27 Sep 2016
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic ConditionStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yukio Sonoda, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923544
- Sponsor's protocol ID
- 16-1397
- Status last verified
- May 2022
- First submitted
- 3 Oct 2016
- Last updated
- 4 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of YUMI Uterine Manipulator
- ClinicalTrials.gov ID
- NCT02923544
- Acronym / sponsor ID
- 16-1397
- Conditions
- Gynecologic Condition, Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy
- Keywords
- Uterine Manipulator, Yukio's Uterine Manipulating Instrument (YUMI), 16-1397
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total laparoscopic or robotic-assisted hysterectomy | Experimental | Procedure: YUMI manipulatorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participant is not eligible if the surgeon does not plan to use a uterine manipulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YUMI manipulatorAlso: Yukio's Uterine Manipulating Instrument | Procedure or surgery | total laparoscopic or robotic-assisted hysterectomy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukio Sonoda, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YUMI manipulator in people with Gynecologic Condition and Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of successfully placed Uterine Manipulator (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.