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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032098
Receipt No. 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 2018/04/04

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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
Obsterics 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
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
Email 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
Email ytakei@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
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 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
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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 20 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 04 Month 04 Day
Last modified on
2018 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036622

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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