UMIN-CTR Clinical Trial

Basic information
Public title	Urolithiasis Recurrence Prevention Program
Acronym	Urolithiasis Recurrence Prevention Program
Scientific Title	Urolithiasis Recurrence Prevention Program
Scientific Title:Acronym	Urolithiasis Recurrence Prevention Program
Region	Japan

Condition
Condition	Urolithiasis
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Creating an effective program to prevent urolithiasis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to recurrence-free urolithiasis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Dietary and Nutritional Guidance
Interventions/Control_2
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	Patients diagnosed with urolithiasis
Key exclusion criteria	Patients who have requested not to participate in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Go Middle name Last name Anan
Organization	Yotsuya Medical Cube
Division name	Urology
Zip code	1020084
Address	7-7 Nibancho, Chiyoda-ku, Tokyo
TEL	03-3261-0401
Email	g-anan@mcube.jp

Public contact
Name of contact person	1st name Go Middle name Last name Anan
Organization	Yotsuya Medical Cube
Division name	Urology
Zip code	1020084
Address	7-7 Nibancho, Chiyoda-ku, Tokyo
TEL	03-3261-0401
Homepage URL
Email	g-anan@mcube.jp

Sponsor
Institute	Yotsuya Medical Cube
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Management Department, Yotsuya Medical Cube
Address	7-7 Nibancho, Chiyoda-ku, Tokyo
Tel	03-3261-0401
Email	ymc_rinsyou@mcube.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	2022 Year 05 Month 18 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	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 18 Day
Date of IRB	2022 Year 05 Month 10 Day
Anticipated trial start date	2022 Year 05 Month 18 Day
Last follow-up date	2031 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	2022 Year 05 Month 18 Day
Last modified on	2022 Year 05 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054480

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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