UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of endovascular laser ablation for varicose vein
Title of the study (Brief title)	Clinical study of endovascular laser ablation for varicose vein
Region	Japan

Condition
Condition	varicose veins
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study the safety and effectiveness of newly developed endovascular laser equipment and fiber for varicose vein
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Venous occlusion rate at 12 weeks after surgery
Key secondary outcomes	The incidence of adverse events on 1 day, 1 week, 4 weeks and 12 weeks after surgery

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Endovascular laser ablation for varicose vein
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients satisfying all the indications for endovascular therapy in "Endovascular treatment guidelines for varicose veins" Patients who agreed to participate in this study Patients who can go to the outpatient hospital until 12 weeks after surgery
Key exclusion criteria	Patients falling under any of the exclusion criteria in "Endovascular treatment guidelines for varicose veins" Patient judged inappropriate by the attending physician
Target sample size	10

Research contact person
Name of lead principal investigator	Taijiro Sueda
Organization	Hiroshima University Hospital
Division name	Cardiovascular Surgery
Address	1-2- 3 Kasumi Minami-ku Hiroshima-city
TEL	082-257-5215
Email	sueda@hiroshima-u.ac.jp

Public contact
Name of contact person	Tatsuya Kurosaki
Organization	Hiroshima University Hospital
Division name	Cardiovascular Surgery
Address	1-2- 3 Kasumi Minami-ku Hiroshima-city
TEL	082-257-5215
Homepage URL
Email	kurosakt@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035267