UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055469 |
|---|---|
| Receipt number | R000063382 |
| Scientific Title | Cost-effectiveness comparison between reusable and single-use ureteroscopes in endoscopic combined intrarenal surgery for large upper urinary stones |
| Date of disclosure of the study information | 2024/09/10 |
| Last modified on | 2024/09/10 06:46:58 |
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Basic information
Public title
Cost-effectiveness between reusable and single-use ureteroscopes in treatment for large renal stones
Acronym
Comparison between reusable and single-use ureteroscopes
Scientific Title
Cost-effectiveness comparison between reusable and single-use ureteroscopes in endoscopic combined intrarenal surgery for large upper urinary stones
Scientific Title:Acronym
Comparison between reusable and single-use ureteroscopes in ECIRS
Region
| Japan |
Condition
Condition
upper urinary stone disease
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surgical treatments for urolithiasis include ureteroscopy, percutaneous nephrolithotomy, and endoscopic combined intrarenal surgery (ECIRS), with flexible ureteroscopes being widely used among them. In addition to traditional reusable flexible ureteroscopes, single-use flexible ureteroscopes have been developed in recent years and are increasingly utilized. However, a comprehensive comparison of the two types, including aspects such as medical costs, treatment outcomes, and complications such as infections, is necessary. In this study, to enable the optimal use of ureteroscopes for each case, we will randomly assign patients requiring ECIRS for renal and upper ureteral stones to one of the two types of ureteroscopes and compare treatment outcomes and medical costs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Case numbers and medical cost before reusable flexible ureteroscope breakage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are 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
Reusable flexible ureteroscopy usage for ECIRS to treat large kidney stones
Interventions/Control_2
Single-use flexible ureteroscopy usage for ECIRS to treat large kidney stones
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with renal and/or upper ureteral stones at Nagoya City University Hospital, and planned for percutaneous nephrolithotomy
2) Stones for 15mm and larger in size
3) Patients who were obtained written informed consent
- obtained written informed consent from themselves if they are 18 years old and older
- obtained written informed consent from themselves and representatives if their ages are between 16 and 17 years old
Key exclusion criteria
A) women with pregnant or its possibility
B) having active pyelonephritis
C) under anti-platelet/coagulation therapy within 1 week prior surgery
D) difficult status for general/lumber anesthesia judged by anesthesiologist
E) Best supportive care due to terminal carcinoma
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Taguchi |
Organization
Nagoya City University
Division name
Nephro-urology
Zip code
4678601
Address
Kawasumi 1, Mizuho-cho, Miziho-ku, Nagoya
TEL
0528538266
ktaguchi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Taguchi |
Organization
Nagoya City University
Division name
Nephro-urology
Zip code
4678601
Address
Kawasumi 1, Mizuho-cho, Miziho-ku, Nagoya
TEL
0528538266
Homepage URL
ktaguchi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya City University medical research review board
Address
Kawasumi 1, Mizuho-cho, Miziho-ku, Nagoya
Tel
0528587215
clinical_research@med.nagoya-cu.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
| 2024 | Year | 09 | Month | 10 | 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
179
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063382
