UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060173 |
|---|---|
| Receipt number | R000068776 |
| Scientific Title | A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery |
| Date of disclosure of the study information | 2025/12/24 |
| Last modified on | 2025/12/23 11:19:59 |
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Basic information
Public title
A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery
Acronym
A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery
Scientific Title
A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery
Scientific Title:Acronym
A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery
Region
| Japan |
Condition
Condition
Patients undergoing total hysterectomy via minimally invasive surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the Usefulness of an AI Program for Minimally Invasive Surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate for intraoperative or postoperative urinary tract (ureter or bladder) injury of Grade IIIa or higher
Key secondary outcomes
1. Adverse event rate of intraoperative and postoperative urinary tract injuries of Grade II or higher
2. Adverse event rate of intraoperative and postoperative urinary tract injuries of Grade I or higher
3. Surgeon stress level (Visual analogue scale using TLX score, etc.)
4. Contribution of the system to surgery (Visual analogue scale)
5. Contribution of the system to surgical education (Visual analogue scale)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of an AI program for Minimally Invasive Hysterectomy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing total hysterectomy via minimally invasive surgery
Must meet all of the following eligibility criteria:
1.Adult patients scheduled for laparoscopic or robot-assisted total hysterectomy
2.Patients who have provided written informed consent to participate in this study of their own free will
Physicians using this system
Surgeons and assistants who use this system for laparoscopic or robot-assisted total hysterectomy. However, participation is limited to surgeons and assistants who have never used SurVisHys, or who have used it in 10 or fewer cases and have not used it for at least 3 months at the time of participation.
Key exclusion criteria
Patients undergoing total hysterectomy via minimally invasive surgery
Must not meet any of the following exclusion criteria:
1.Minors
2.Patients deemed unsuitable for participation in this study by their attending physician
3.Patients judged to have a high risk of urinary tract injury preoperatively and scheduled to receive ureteral stent placement
Physicians using this system
Physicians deemed unsuitable for participation in this study by the principal investigator at each facility. However, in principle, we plan to collect questionnaire responses from all physicians capable of responding.
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takenaka |
Organization
Department of Obstetrics and Gynecology, Showa Medical University / Gynecology, National Cancer Center Hospital East
Division name
Department of Obstetrics and Gynecology, Showa Medical University / Gynecology, National Cancer Center Hospital East
Zip code
142-8666/277-8577
Address
1-5-8 Hatano-dai, Shinagawa-ku, Tokyo / 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL
03-3784-8551
shin-take@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Nakabayashi |
Organization
Showa Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
142-8666
Address
1-5-8 Hatano-dai, Shinagawa-ku, Tokyo
TEL
03-3784-8551
Homepage URL
nakabayashi@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Showa Medical University / Gynecology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jmees Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
104-0045 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
-
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068776
