UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042161