UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042837 |
|---|---|
| Receipt number | R000048905 |
| Scientific Title | The safety of ureteroscopic lithotripsy for the elderly patients |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/12/28 19:50:32 |
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Basic information
Public title
The safety of ureteroscopic lithotripsy for the elderly patients
Acronym
The safety of ureteroscopic lithotripsy for the elderly patients
Scientific Title
The safety of ureteroscopic lithotripsy for the elderly patients
Scientific Title:Acronym
The safety of ureteroscopic lithotripsy for the elderly patients
Region
| Japan |
Condition
Condition
upper urinary tract stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of ureteroscopic lithotripsy for the elderly patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative complications and their types
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 105 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ureteroscopic lithotripsy for the first time in our institution from April 2016 to March 2020 are included.
Key exclusion criteria
Patients who underwent repeated ureteroscopic lithotripsy within 2 months, PNL or only ureteral stent placement.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Takazawa |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
170-8476
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
TEL
0339413211
angel_sapporo_0329@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Takazawa |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
170-8476
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
TEL
0339413211
Homepage URL
angel_sapporo_0329@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Ohtsuka Hospital
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
Tokyo Metropolitan Ohtsuka Hospital
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
Tel
0339413211
angel_sapporo_0329@yahoo.co.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
| 2021 | Year | 04 | 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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048905
| 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 |
