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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037006
Receipt No. 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 2019/06/09

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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
Email 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
Email yoshidtk@takii.kmu.ac.jp

Sponsor
Institute Department of Urology and Andrology, Kansai medical university
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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