UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038550 |
|---|---|
| Receipt number | R000043930 |
| Scientific Title | Clinical study of preoperative explanation using a 3D-kidney model by a 3D-printer |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2020/11/12 01:20:40 |
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Basic information
Public title
Clinical study of preoperative explanation using a 3D-kidney model by a 3D-printer
Acronym
Preoperative explanatory study using a 3D-kidney model
Scientific Title
Clinical study of preoperative explanation using a 3D-kidney model by a 3D-printer
Scientific Title:Acronym
Preoperative explanatory study using a 3D-kidney model
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate whether the use of a 3D-kidney model for preoperative explanation improves the patient's and their family's understanding of the disease and satisfaction with the preoperative explanation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is patients' understanding of the disease obtained from the questionnaire results conducted on the same day after the preoperative explanation.
Key secondary outcomes
The patient's satisfaction with the preoperative explanation obtained from the questionnaire results.
The value of the model in the preoperative explanation obtained from the questionnaire results.
The understanding and satisfaction of the patient's family with the preoperative explanation obtained from the questionnaire results.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Explaining the operation using a 3-D kidney model.
Interventions/Control_2
Explaining the operation as usual (without using a 3-D kidney model).
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo partial nephrectomy at our Hospital.
Patients who have undergone MRI or contrast-enhanced CT at our hospital before surgery.
Patients who have consent to participate in the study and their families.
Key exclusion criteria
Patients who could not undergo MRI or contrast-enhanced CT at our hospital one month before surgery.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Jichi Medical University
Division name
Urology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7379
myyamazz73@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Jichi Medical University
Division name
Urology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7379
Homepage URL
myyamazz73@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-7379
rinri@jichi.ac.jp
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
| 2019 | Year | 11 | Month | 12 | 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
30
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
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043930
