UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032098 |
|---|---|
| Receipt number | R000036622 |
| Scientific Title | The clinical study of robotic assisted uterine cancer surgery using the da Vinci Si Surgical System. |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2020/04/05 10:13:38 |
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Basic information
Public title
The clinical study of robotic assisted uterine cancer surgery using the da Vinci Si Surgical System.
Acronym
The clinical study of robotic assisted uterine cancer surgery using the da Vinci Si Surgical System.
Scientific Title
The clinical study of robotic assisted uterine cancer surgery using the da Vinci Si Surgical System.
Scientific Title:Acronym
The clinical study of robotic assisted uterine cancer surgery using the da Vinci Si Surgical System.
Region
| Japan |
Condition
Condition
cervical cancer, endometrial cancer
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 assited surgery for cervical cancer and endometrial cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood loss
Key secondary outcomes
operation 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 radical hysterectomy (including pelvic lymphadenectomy)
robotic assisted modified radical hysterectomy (including 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. cervical cancer or endometrial cancer.
2. clinical stage IA or IB1 in cervical cancer.
3. clinical stage I in endometrial cancer.
Key exclusion criteria
1. patients with severe complications.
2. patients who are judged to be inappropriate to carry out the study by medical attendant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
329-0498
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 | Yuji |
| Middle name | |
| Last name | Takei |
Organization
Jichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
329-0498
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
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
Institutional Review Board, Jichi Medical University Hospital
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
Tel
0285-58-7550
rinri@jichi.ac.jp
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 05 | 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
2
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
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036622
