UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018766 |
|---|---|
| Receipt number | R000021710 |
| Scientific Title | The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System. |
| Date of disclosure of the study information | 2015/08/22 |
| Last modified on | 2018/08/24 14:07:46 |
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Basic information
Public title
The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Acronym
The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Scientific Title
The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Scientific Title:Acronym
The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Region
| Japan |
Condition
Condition
endometrial cancer, atypical endometrial hyperplasia, submucosal leiomyoma, endometrial polyp
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the evaluation for safety and usefulness of robotic assisted surgery for gynecologic disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operation time, blood loss.
Key secondary outcomes
aesthesia time, complications, postoperative pain-killer use frequency, duration of hospitalization.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
robotic assisted gynecologic surgery (total hysterectomy, bilateral salpingo oophorectomy, pelvic lymphadenectomy)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. endometrial cancer, atypical endometrial hyperplasia, submucosal leiomyoma, endometrial polyp.
2. In the case of endometrial cancer, clinical stage is FIGO IA and IB.
Key exclusion criteria
1. Patients with severe complications.
2. Patients who are judged to be inappropriate to carry out the study by the medical attendant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL
0285-58-7376
ytakei@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL
0285-58-7376
Homepage URL
ytakei@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Jichi Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021710
