UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039822 |
|---|---|
| Receipt number | R000045413 |
| Scientific Title | A prospective study of GreenLight XPSfor BPH |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2020/03/15 12:23:00 |
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Basic information
Public title
A prospective study of GreenLight XPS for BPH
Acronym
Analysis of vaporization treatment for BPH
Scientific Title
A prospective study of GreenLight XPSfor BPH
Scientific Title:Acronym
Analysis of vaporization treatment for BPH
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis effective of PVP-XPS for BPH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS,QOL,Qmax,PVR
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male
Key inclusion criteria
50 year old>
IPSS>7
QOL>1
prostatic volume>30
Key exclusion criteria
neurogenic bladder
Having obstruction lesion other than BPH
History of surgery for BPH
prostate cancer
Inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Seki |
| Middle name | |
| Last name | Narihito |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Division name
Department of Urology
Zip code
8158588
Address
Shiobaru3-13-1, Minami-ku, Fukuoka, Fukuoka, Japan
TEL
092-541-4936
dejima@uro.med.kyushu-uac.jp
Public contact
Name of contact person
| 1st name | Dejima |
| Middle name | |
| Last name | Takashi |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Division name
Department of Urology
Zip code
8158588
Address
Shiobaru3-13-1, Minami-ku, Fukuoka, Fukuoka, Japan
TEL
092-541-4936
Homepage URL
dejima@uro.med.kyushu-uac.jp
Sponsor or person
Institute
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Address
Shiobaru3-13-1,Minami-ku, Fukuoka Fukuoka, Japan
Tel
092-541-4936
dejima@uro.med.kyushu-uac.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
| 2020 | Year | 03 | Month | 15 | 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
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045413
