UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028590 |
|---|---|
| Receipt number | R000032692 |
| Scientific Title | Safety and Efficacy of Quartz Head Laser Ablation for the Prostate Using 980-nm Laser in Patients With Ongoing Platelet Aggregation Inhibition and Oral Anticoagulation |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2019/02/15 21:16:18 |
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Basic information
Public title
Safety and Efficacy of Quartz Head Laser Ablation for the Prostate Using 980-nm Laser in Patients With Ongoing Platelet Aggregation Inhibition and Oral Anticoagulation
Acronym
Safety and Efficacy of Quartz Head Laser Ablation for the prostate Using 980-nm Laser
Scientific Title
Safety and Efficacy of Quartz Head Laser Ablation for the Prostate Using 980-nm Laser in Patients With Ongoing Platelet Aggregation Inhibition and Oral Anticoagulation
Scientific Title:Acronym
Safety and Efficacy of Quartz Head Laser Ablation for the prostate Using 980-nm Laser
Region
| Japan |
Condition
Condition
benign prostatic hypertrophy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the improvement in voiding symptom and the postoperative bleeding-related complication rate between those on anticoagulation versus those who were not undergoing Quartz Head Laser Ablation for the Prostate Using 980-nm diode Laser.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative hematuria leading to urethral catheter obstruction.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. >50 years old
2. prostate volume >30cc
3. Meet the criteria for the surgery according to "Clinical Guidelines for Male Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia" 2017
Key exclusion criteria
1. Individual may not complete 12 months follow up
2. Unable to provide informed consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku Tokyo, 160-8582
TEL
03-5363-3825
t-shinoj@cd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku Tokyo, 160-8582
TEL
03-5363-3825
Homepage URL
t-shinoj@cd5.so-net.ne.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Integral Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the improvement in voiding symptom and the postoperative bleeding-related complication rate would be evaluated in patients receiving Quartz Head Laser Ablation for the Prostate Using 980-nm diode Laser. The results would be compared between those on anticoagulation versus those who were not.
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032692
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
