Unique ID issued by UMIN | UMIN000002230 |
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Receipt number | 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 10:48:55 |
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
ELVC for BPH
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
ELVC for BPH
Japan |
BPH
Urology |
Others
NO
Phase 2 trial to study the feasibility and effectiveness of ELVC using ICG solution and Diode laser for BPH
Bio-equivalence
Confirmatory
Pragmatic
Phase II
6 months after the treatment
IPSS,the prostatic volume,flow study,QOL at 2,4 weeks and 3,6 months after the treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
No treatment
1
Treatment
Device,equipment | Maneuver |
ELVC therapy as a primary treatment
40 | years-old | <= |
80 | years-old | >= |
Male
1.BPH;prostatic volume more than 50cc, amount of residual urine more than 50cc
2.written informed consent
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
10
1st name | |
Middle name | |
Last name | Shigehiro Kubota |
Kanda Ishin Clinic
Department of Urology
2-2-13,Iwamoto-cho,Chiyoda-ku,Tokyo,101-0032,Japan
03-5833-3240
1st name | |
Middle name | |
Last name | Shigehiro Kubota |
Kanda Ishin Clinic
Department of Urology
2-2-13,Iwamoto-cho,Chiyoda-ku,Tokyo,101-0032,Japan
03-5833-3240
postmaster@ishin-kai.or.jp
Ishinkai
None
Self funding
None
NO
2009 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2009 | Year | 05 | Month | 28 | Day |
2009 | Year | 08 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2009 | Year | 07 | Month | 21 | Day |
2010 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002734
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