UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026298 |
|---|---|
| Receipt number | R000030203 |
| Scientific Title | The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Cervial Cancer |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2019/04/18 16:03:03 |
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Basic information
Public title
The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Cervial Cancer
Acronym
The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Cervial Cancer
Scientific Title
The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Cervial Cancer
Scientific Title:Acronym
The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Cervial Cancer
Region
| Japan |
Condition
Condition
Cervical Cancer
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS) for patient with Cervial Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and Efficacy
Key secondary outcomes
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 Simple / modified-Radical and Radical Hysterectomy (DVSS)
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
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
CIN3, Cervical Cancer Stage:1A1,1A2, 1B1,1B2, 2A1, 2A2, 2B
1)Performance Status(P.S.) 0-1
2)Age: 25-75
3)No lymph node meta and No metastasis for the other organs inside the abdomen
Key exclusion criteria
No complications, not pregnant women
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kondo |
Organization
Mie University Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
eijikon@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kondo |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
Homepage URL
eijikon@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Mie University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Mie University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030203
