UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059022 |
|---|---|
| Receipt number | R000057835 |
| Scientific Title | Prospective cohort study analyzing the incidence of infectious complications of URSL using a flexible ureteroscope (LithoVue Elite) with intrarenal pelvic pressure monitoring. |
| Date of disclosure of the study information | 2025/09/07 |
| Last modified on | 2025/09/07 06:41:05 |
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Basic information
Public title
Prospective cohort study analyzing the incidence of infectious complications of URSL using a flexible ureteroscope (LithoVue Elite) with intrarenal pelvic pressure monitoring.
Acronym
Prospective cohort studyr analyzing the efficacy of LithoVue Elite during URSL
Scientific Title
Prospective cohort study analyzing the incidence of infectious complications of URSL using a flexible ureteroscope (LithoVue Elite) with intrarenal pelvic pressure monitoring.
Scientific Title:Acronym
Prospective cohort studyr analyzing the efficacy of LithoVue Elite during URSL
Region
| Japan |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy of LithoVue Elite to prevent the peri-operative infectious complicaions during URSL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative fever (>38 degree)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Patients with upper tract calculi to be treated by flexible ureteroscopy
2, preoperative positive urinary culture
3, more than 20 years old
4, Patients who agree to participate in the study
Key exclusion criteria
1, Patients with active urinary tract infections
2, Patients with malignant cancers
3, Patients who can not be performed general anesthesia
4, Patients who were performed URS within 3 months
5, Patients with percutaneous nephrostomy
6, Pregnant female
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8266
hamamo10@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shuzo |
| Middle name | |
| Last name | Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8266
Homepage URL
hamamo10@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Shuzo Hamamoto
Funding Source
Organization
Boston Scientific Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Univeresity Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-853-8266
hamamo10@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
| 2025 | Year | 09 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2025 | Year | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057835
