UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026919 |
|---|---|
| Receipt number | R000030881 |
| Scientific Title | The development of new uterine manipulator for uterine malignancies |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/10/15 18:34:59 |
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Basic information
Public title
The development of new uterine manipulator for uterine malignancies
Acronym
The development of new uterine manipulator
Scientific Title
The development of new uterine manipulator for uterine malignancies
Scientific Title:Acronym
The development of new uterine manipulator
Region
| Japan |
Condition
Condition
endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of safety and efficacy of new uterine manipulater for endometrial cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Peri-operative complication
Key secondary outcomes
post operative survival time and disease free survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
use the new uterine manipulator and examine the safety and efficacy of the new manipulator
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
| Not applicable |
Gender
Female
Key inclusion criteria
stage IA endometrial cancer
aged over 20 yo
patient with informed consent
Key exclusion criteria
narrow vagina
severe comorbidity
PS > 2
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kobayashi Eiji |
Organization
Osaka University
Division name
OB GYN
Zip code
Address
Suita City, yamadaoka 2-2
TEL
0668793355
ekobayashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi Eiji |
Organization
Osaka University
Division name
OBGYN
Zip code
Address
Suita City, yamadaoka 2-2
TEL
0668793355
Homepage URL
ekobayashi@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
OBGYN
Institute
Department
Personal name
Funding Source
Organization
Osaka university
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 01 | 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 | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
