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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030951
Receipt No. R000035338
Scientific Title The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Endometrial Carcinoma
Date of disclosure of the study information 2018/01/23
Last modified on 2018/01/23

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Basic information
Public title The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Endometrial Carcinoma
Acronym The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Endometrial Carcinoma
Scientific Title The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Endometrial Carcinoma
Scientific Title:Acronym The safety and efficacy of Robotic Simple / modified-Radical and Radical Hysterectomy (DVSS)for patient with Endometrial Carcinoma
Region
Japan

Condition
Condition Endometrial Carcinoma
Classification by specialty
Obsterics and gynecology Operative medicine Adult
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 Endometrial Carcinoma
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 Endometrial carcinoma Stage:1A, 1B, 2

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 5

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
Email eijikon@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
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
Homepage URL
Email eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Mie University School of Medicine
Institute
Department

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
Email

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
2018 Year 01 Month 23 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 11 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
2018 Year 01 Month 23 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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