Trial of YUMI Uterine Manipulator

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2022-05-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Trial of the Robotic Uterine Manipulator

NCT03517228

Gynecologic Surgery

TERMINATED NA

Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study

NCT05242276

Endometrial Cancer

RECRUITING

Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY

NCT02762214

Endometrial Cancer

UNKNOWN PHASE3

Evaluation of Laparoscopic Hysterectomy Simulator

NCT02234856

Evaluation of Laparoscopic Hysterectomy Simulator

COMPLETED NA

Utilization of Uterine Manipulator in Abdominal Hysterectomy

NCT03943485

Sexual Function Disturbances

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Condition Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

YUMI manipulator

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YUMI manipulator

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Yukio's Uterine Manipulating Instrument

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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