UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053969 |
|---|---|
| Receipt number | R000061601 |
| Scientific Title | Efficacy of Moses Technology versus non-Moses Technology during retrograde intrarenal surgery: a randomized controlled trail |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/03/25 20:05:16 |
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Basic information
Public title
Efficacy of Moses Technology versus non-Moses Technology during retrograde intrarenal surgery: a randomized controlled trail
Acronym
Moses comparative trial
Scientific Title
Efficacy of Moses Technology versus non-Moses Technology during retrograde intrarenal surgery: a randomized controlled trail
Scientific Title:Acronym
Moses comparative trial
Region
| Japan |
Condition
Condition
Kidney and ureteral stones
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the efficacy between using Moses Technology and non-Moses Technology for the patient with kidney or ureteral stones during flexible ureteroscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total operative time between Moses and non-Moses technology
Key secondary outcomes
Ureteroscopy time
Stone free rate on postoperative 1mo
Stone free rate on postoperative 3mo
Total laser time (sec)
Total laser energy (J)
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Moses group
2 groups are randomized between Moses Technology mode and non-Moses mode (Short pulse mode)
Interventions/Control_2
Non-Moses group
(Short pulse group)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Performance status<1
Stone size in kidney and ureter (15mm< stone <30mm)
Patient who hopes to use flexible ureteroscopy
Patient who can understand the explanation to join this study
Key exclusion criteria
Patient with difficulty of communication
Patient with anomaly genitourinary system
Patient with pregnant
Patients with a body mass index (BMI) greater than 45
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Inoue |
Organization
Hara Genitourinary hospital
Division name
Urology
Zip code
6500012
Address
5-7-17, Kitagasa-Touri, Tyuo-ku, Kobe City
TEL
+81783711203
inouetak@harahospital.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Inoue |
Organization
Hara Genitourinary hospital
Division name
Urology
Zip code
6500012
Address
5-7-17, Kitagasa-Touri, Tyuo-ku, Kobe City
TEL
+81783711203
Homepage URL
inouetak@harahospital.jp
Sponsor or person
Institute
Hara Genitourinary hospital
Institute
Department
Personal name
Funding Source
Organization
Bostone Scientific US
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United status
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hosital
Address
5-2 Kusunomi-tyo, Tyuo-ku Kobe City
Tel
+81783825111
+81783825111
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 | 07 | Month | 01 | 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
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061601
