UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062581 |
|---|---|
| Receipt number | R000071634 |
| Scientific Title | Efficacy and Safety of Transurethral Laser Ablation Using a Pulsed Thulium:YAG Laser for Recurrent Low-Grade Non-Muscle-Invasive Bladder Cancer |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/14 19:53:43 |
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Basic information
Public title
Efficacy and Safety of Transurethral Laser Ablation Using a Pulsed Thulium:YAG Laser for Recurrent Low-Grade Non-Muscle-Invasive Bladder Cancer
Acronym
Efficacy and Safety of Transurethral Laser Ablation Using a Pulsed Thulium:YAG Laser for Recurrent Low-Grade Non-Muscle-Invasive Bladder Cancer
Scientific Title
Efficacy and Safety of Transurethral Laser Ablation Using a Pulsed Thulium:YAG Laser for Recurrent Low-Grade Non-Muscle-Invasive Bladder Cancer
Scientific Title:Acronym
Efficacy and Safety of Transurethral Laser Ablation Using a Pulsed Thulium:YAG Laser for Recurrent Low-Grade Non-Muscle-Invasive Bladder Cancer
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective, single-center study will be conducted to evaluate the efficacy and safety of transurethral laser ablation using a pulsed thulium:YAG laser without anesthesia in patients with recurrent low-grade non-muscle-invasive bladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment efficacy and prognosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transurethral laser ablation using a pulsed thulium:YAG laser will be performed without anesthesia.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a history of low-grade non-muscle-invasive bladder cancer who have experienced intravesical recurrence
Clinical TNM stage: Stage 0
Key exclusion criteria
Patients who decline to participate in this study
Patients whom the principal investigator determines to be inappropriate for inclusion in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Ikeda |
Organization
Saiseikai Noe Hospital
Division name
Urology
Zip code
536-0001
Address
3-25 Furuichi, Joto-ku, Osaka, Japan
TEL
06-6932-7977
ikedaj1985@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Ikeda |
Organization
Saiseikai Noe Hospital
Division name
Urology
Zip code
536-0001
Address
3-25 Furuichi, Joto-ku, Osaka, Japan
TEL
06-6932-7977
Homepage URL
ikedaj1985@gmail.com
Sponsor or person
Institute
Saiseikai Noe Hospital
Institute
Department
Personal name
Junichi Ikeda
Funding Source
Organization
No funding is required for this study.
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
Saiseikai Noe Hospital
Address
3-25 Furuichi, Joto-ku, Osaka, Japan
Tel
06-6932-7977
ikedaj1985@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
| 2026 | Year | 08 | Month | 24 | 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
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071634
