UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037006 |
|---|---|
| Receipt number | R000042161 |
| Scientific Title | Comparison of Polaris Ultra Ureteral Stent and Tria Firm Ureteral Stent on Deposition of Encrustation Following Short-Term Placement: A Prospective, Single-blind, Randomized Controlled Trial. |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2020/12/09 13:54:47 |
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Basic information
Public title
Comparison of Polaris Ultra Ureteral Stent and Tria Firm Ureteral Stent on Deposition of Encrustation Following Short-Term Placement: A Prospective, Single-blind, Randomized Controlled Trial.
Acronym
Comparison of Polaris Ultra Ureteral Stent and Tria Firm Ureteral Stent on Deposition of Encrustation Following Short-Term Placement
Scientific Title
Comparison of Polaris Ultra Ureteral Stent and Tria Firm Ureteral Stent on Deposition of Encrustation Following Short-Term Placement: A Prospective, Single-blind, Randomized Controlled Trial.
Scientific Title:Acronym
Comparison of Polaris Ultra Ureteral Stent and Tria Firm Ureteral Stent on Deposition of Encrustation Following Short-Term Placement
Region
| Japan |
Condition
Condition
Patients with urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether Tria Firm Ureteral Stent prevents the deposition of encrustation compared to Polaris Ultra Ureteral Stent after short-term placement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Encrustation volume in inner wall of the ureteral stent (mm3)
Key secondary outcomes
1. Intraluminal obstruction rate (%) (at the narrowest point of the stent)
2. Outerwall stent encrustation volume (mm3)
3. Outerwall stent encrustation-sectional volume: proximal/body/distal (mm3)
4. Hydronephrosis grade before removal of stents
5. Stent-related complications (Dislodgment, migration, UTI, readmission etc.)
6. Stone composition (stone fragments, encrustation stone)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Placement of Tria Firm Ureteral Stent during 14 days postoperatively
Interventions/Control_2
Placement of Polaris Ultra Ureteral Stent during 14 days postoperatively
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.>20 year-old adults
2.Patients undergoing ureteroscopy (URS) for renal and/or ureteral stones
3.Patients with informed consent
Key exclusion criteria
1. Patients potentially requiring ureteric stent placement for >14 days postoperatively
2. Patients requiring antibiotics use prior to URS due to the presence of urinary tract infection
3. Pregnant
4. Patients with difficulty of communication
5. patients who have been determined to be unsuitable as a subject by a physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshida |
Organization
Kansai medical university hospita
Division name
Department of Urology and Andrology
Zip code
573-1010
Address
2-3-1 Shin-Machi, Hirakata, 573-1010, Osaka, Japan
TEL
072-804-0101
yoshidtk@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshida |
Organization
Kansai medical university hospital
Division name
Department of Urology and Andrology
Zip code
573-1010
Address
2-3-1 Shin-Machi, Hirakata, 573-1010, Osaka, Japan
TEL
072-804-0101
Homepage URL
yoshidtk@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Urology and Andrology, Kansai medical university
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
Kansai medical university, Department of phisic
Kansai medical university, kori hospital
Wakayama prefectureal medical univeresity hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Committee of Kansai medical university
Address
2-3-1 Shin-Machi, Hirakata, 573-1191, Osaka, Japan
Tel
(072)-804-2083
kenkyu@hirakata.kmu.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
| 2019 | Year | 06 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042161
