UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029925
Receipt No. R000034187
Scientific Title Robot-assisted pyeloplasty
Date of disclosure of the study information 2018/01/10
Last modified on 2019/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Robot-assisted pyeloplasty
Acronym Robot-assisted pyeloplasty
Scientific Title Robot-assisted pyeloplasty
Scientific Title:Acronym Robot-assisted pyeloplasty
Region
Japan

Condition
Condition ureteropelvic junction stenosis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of robot-assisted pyeloplasty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes success rate
Key secondary outcomes blood loss, operative time, complication rate, length of hospital stay

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 robot-assisted pyeloplasty
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA class 2 or below
ECOG PS 1 or below
age 20-
BMI 35kg/m2 or below
Key exclusion criteria history of upper abdominal opearation ( excluding laparoscopic cholecystectomy)
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Ishida
Organization Saiseikai Yokohamashi Tobu Hospital
Division name Department of Urology
Zip code 230-8765
Address 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
TEL 045-576-3000
Email m_ishida@tobu.saiseikai.or.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Ishida
Organization Saiseikai Yokohamashi Tobu Hospital
Division name Department of Urology
Zip code 230-8765
Address 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
TEL 045-576-3000
Homepage URL
Email m_ishida@tobu.saiseikai.or.jp

Sponsor
Institute Saiseikai Yokohamashi Tobu Hospital
Institute
Department

Funding Source
Organization Saiseikai Yokohamashi Tobu Hospital
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 Ethical Committee of Saiseikai Yokohamashi Tobu Hospital
Address 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
Tel 045-576-3000
Email f_sawa@tobu.saiseikai.or.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
2018 Year 01 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
2018 Year 01 Month 30 Day
Anticipated trial start date
2018 Year 02 Month 01 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
2017 Year 11 Month 10 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.