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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002230
Receipt No. R000002734
Scientific Title The study of feasibility and effectiveness of enhanced laser vapolization and coagulation(ELVC)using indocyanine green(ICG) solution and Diode laser for benigin prostatic hyperplasia(BPH):A phase 2 Trial
Date of disclosure of the study information 2009/08/01
Last modified on 2010/04/20

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Basic information
Public title The study of feasibility and effectiveness of enhanced laser vapolization and coagulation(ELVC)using indocyanine green(ICG) solution and Diode laser for benigin prostatic hyperplasia(BPH):A phase 2 Trial
Acronym ELVC for BPH
Scientific Title The study of feasibility and effectiveness of enhanced laser vapolization and coagulation(ELVC)using indocyanine green(ICG) solution and Diode laser for benigin prostatic hyperplasia(BPH):A phase 2 Trial
Scientific Title:Acronym ELVC for BPH
Region
Japan

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

Objectives
Narrative objectives1 Phase 2 trial to study the feasibility and effectiveness of ELVC using ICG solution and Diode laser for BPH
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 6 months after the treatment
Key secondary outcomes IPSS,the prostatic volume,flow study,QOL at 2,4 weeks and 3,6 months after the treatment

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 ELVC therapy as a primary treatment
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria 1.BPH;prostatic volume more than 50cc, amount of residual urine more than 50cc
2.written informed consent
Key exclusion criteria 1.Prostatic cancer
2.Patients with serious comobidities;serious cardiac complications such as uncontrollable angaina,myocardal infaraction within 3 months,heart failure,arrythemia required treatment,uncontrollable daibetes mellitus and hypertion
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigehiro Kubota
Organization Kanda Ishin Clinic
Division name Department of Urology
Zip code
Address 2-2-13,Iwamoto-cho,Chiyoda-ku,Tokyo,101-0032,Japan
TEL 03-5833-3240
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigehiro Kubota
Organization Kanda Ishin Clinic
Division name Department of Urology
Zip code
Address 2-2-13,Iwamoto-cho,Chiyoda-ku,Tokyo,101-0032,Japan
TEL 03-5833-3240
Homepage URL
Email postmaster@ishin-kai.or.jp

Sponsor
Institute Ishinkai
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 01 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 Completed
Date of protocol fixation
2009 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 21 Day
Last modified on
2010 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002734

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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