UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058906 |
|---|---|
| Receipt number | R000067368 |
| Scientific Title | The efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath: A Japanese multicenter prospective randomized controlled trial (TFLFANSJapan trial) |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/27 09:00:46 |
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Basic information
Public title
The efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath: A Japanese multicenter prospective randomized controlled trial (TFLFANSJapan trial)
Acronym
TFLFANSJapan trial
Scientific Title
The efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath: A Japanese multicenter prospective randomized controlled trial (TFLFANSJapan trial)
Scientific Title:Acronym
TFLFANSJapan trial
Region
| Japan |
Condition
Condition
renal stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stone-free status at one month postoperatively by CT
Key secondary outcomes
Operative time
Comparison of surgical complications such as fever and hydronephrosis
laser time
Lithotripsy effectiveness
Laser ablation speed
Laser ablation efficiency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone
Interventions/Control_2
thulium fiber laser and conventional access sheath in retrograde intrarenal surgery for renal stone
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with renal stones (stone diameter 10-20 mm) (if multiple renal stones are present, the largest diameter must be 10-20 mm)
Patient deemed eligible for one stage RIRS
Patient for whom written consent to participate in this study has been obtained from the patient themselves, their guardian, or authorized representative
Key exclusion criteria
Patient with anomaly genitourinary system
Patient with ureteral stone
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Yotsuya Medical Cube
Division name
Urology
Zip code
1020084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
g-anan@mcube.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Yotsuya Medical Cube
Division name
Urology
Zip code
1020084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
Homepage URL
g-anan@mcube.jp
Sponsor or person
Institute
Clinical Research Management Department, Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hachinohe Heiwa Hospital, Ohguchi Higashi General Hospital, Tsukuba Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Department, Yotsuya Medical Cube
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
Tel
03-3261-0401
ymc_rinsyou@mcube.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 | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2025 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067368
