UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050301 |
|---|---|
| Receipt number | R000057275 |
| Scientific Title | Investigation of the effectiveness of robot-assisted fluoroscopy-guided renal puncture using a phantom model |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/02/13 15:36:41 |
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Basic information
Public title
Investigation of the efficacy of robot-assisted fluoroscopy-guided renal puncture
Acronym
Investigation of the efficacy of robot-assisted fluoroscopy-guided renal puncture
Scientific Title
Investigation of the effectiveness of robot-assisted fluoroscopy-guided renal puncture using a phantom model
Scientific Title:Acronym
Investigation of the effectiveness of robot-assisted fluoroscopy-guided renal puncture using a phantom model
Region
| Japan |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of robot-assisted fluoroscopically guided renal puncture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Single puncture success rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
robot-assisted fluoroscopy-guided renal puncture
Interventions/Control_2
ultrasound renal puncture
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
none
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Teruaki |
| Middle name | |
| Last name | Sugino |
Organization
Nagoya City University
Division name
Department of Urology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
+81-52-853-8266
suginoteruaki1106@gmail.com
Public contact
Name of contact person
| 1st name | Teruaki |
| Middle name | |
| Last name | Sugino |
Organization
Nagoya City University
Division name
Department of Urology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
+81-52-853-8266
Homepage URL
suginoteruaki1106@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya City University
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
+81-52-853-8266
suginoteruaki1106@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
| 2023 | Year | 02 | Month | 10 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057275
