UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035380
Receipt number R000040317
Scientific Title Bleeding risk 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 2018/12/27
Last modified on 2019/12/25 19:42:49

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Basic information

Public title

Bleeding risk of Quartz Head Laser Ablation for the Prostate Using 980-nm Laser in Patients With Ongoing Platelet Aggregation Inhibition and Oral Anticoagulation

Acronym

Bleeding risk of Quartz Head Laser Ablation for the prostate Using 980-nm Laser

Scientific Title

Bleeding risk 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

Bleeding risk 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 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. Prostate cancer
2. Unable to provide informed consent

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Ryuichi
Middle name
Last name Mizuno

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code

160-8582

Address

35 Shinanomachi, Shinjyuku-ku Tokyo, 160-8582

TEL

03-5363-3825

Email

mizunor@z7.keio.jp


Public contact

Name of contact person

1st name Nobuyuki Tanaka
Middle name
Last name Tanaka

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code

160-8582

Address

35 Shinanomachi, Shinjyuku-ku Tokyo, 160-8582

TEL

03-5363-3825

Homepage URL


Email

urotanaka@a2.keio.jp


Sponsor or person

Institute

Department of Urology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Not applicable

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

Institutional Review Board of Keio University School of Medicine

Address

35 Shinanomachi, Shinjyuku-ku Tokyo, 160-8582

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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 12 Month 27 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

60

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

Enrolling by invitation

Date of protocol fixation

2018 Year 10 Month 26 Day

Date of IRB

2018 Year 12 Month 25 Day

Anticipated trial start date

2019 Year 01 Month 07 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In this study, 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

2018 Year 12 Month 27 Day

Last modified on

2019 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040317


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name