UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049933 |
|---|---|
| Receipt number | R000055330 |
| Scientific Title | Comparison between reusable (URF-V3) and disposable flexible ureteroscope (Wiscope) |
| Date of disclosure of the study information | 2022/12/29 |
| Last modified on | 2023/07/03 12:01:03 |
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Basic information
Public title
Comparison between reusable and disposable flexible ureteroscope
Acronym
Comparison between reusable and disposable flexible ureteroscope
Scientific Title
Comparison between reusable (URF-V3) and disposable flexible ureteroscope (Wiscope)
Scientific Title:Acronym
Comparison between URF-V3 and WiScope
Region
| Japan |
Condition
Condition
Kidney stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cost comparison of flexible ureteroscopes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Costs associated with the use of flexible ureteroscopes
Key secondary outcomes
surgical outcome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
URF-V3
Interventions/Control_2
Wiscope
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Patients diagnosed with kidney stones and scheduled for ECIRS
(b) Age 20 or over and under 80 on the date of obtaining consent
(c) ECOG Performance Status (PS) is 1 or less
(d) Patients with written informed consent
Key exclusion criteria
(a) Patients with poorly controlled diabetes
(b) Patients with abnormal coagulation or who cannot stop anticoagulants
(c) women who are pregnant or may become pregnant;
(d) Patients with BMI more than 35
(e) Patients with ureteral stricture or post-urinary diversion
(f) Patients with preoperative nephrostomy
(g) Patients unable to take modified Valdivia position or prone position
(h) Patient study without general anesthesia
(i) Patients judged inappropriate by the responsible (sub-investigating) physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Teruaki |
| Middle name | |
| Last name | Sugino |
Organization
Nagoya City University
Division name
Department of Urology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8266
suginoteruaki1106@gmail.com
Public contact
Name of contact person
| 1st name | Teruaki |
| Middle name | |
| Last name | Sugino |
Organization
Nagoya City University
Division name
Department of Urology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8266
Homepage URL
suginoteruaki1106@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya City University Hospital
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-853-8266
suginoteruaki1106@gmail.com
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
| 2022 | Year | 12 | Month | 29 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055330
