UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018920 |
|---|---|
| Receipt number | R000021888 |
| Scientific Title | Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi. |
| Date of disclosure of the study information | 2015/09/06 |
| Last modified on | 2018/03/11 11:52:26 |
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Basic information
Public title
Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Acronym
Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Scientific Title
Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Scientific Title:Acronym
Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Region
| Japan |
Condition
Condition
kidney stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of the preoperative simulation using a three-dimensional model
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
success rate, complication rate
Key secondary outcomes
operative time, blood loss
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
| Other |
Interventions/Control_1
Operative simulation using a three-dimensional printing model before the percutaneous nephrolithotomy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with staghorn calculi who are planning to be treated by percutaneous nephrolithotomy.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoji Takazawa |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
Address
2-8-1, Minami-Ohtsuka, Toshima-ku, Tokyo
TEL
03-3941-3211
ryoji_takazawa@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoji Takazawa |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
Address
2-8-1, Minami-Ohtsuka, Toshima-ku, Tokyo
TEL
03-3941-3211
Homepage URL
ryoji_takazawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
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
| 2015 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021888
