UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030887 |
|---|---|
| Receipt number | R000035267 |
| Scientific Title | Clinical study of endovascular laser ablation for varicose vein |
| Date of disclosure of the study information | 2018/01/26 |
| Last modified on | 2019/03/04 12:11:53 |
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Basic information
Public title
Clinical study of endovascular laser ablation for varicose vein
Acronym
Clinical study of endovascular laser ablation for varicose vein
Scientific Title
Clinical study of endovascular laser ablation for varicose vein
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Taijiro Sueda |
Organization
Hiroshima University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
1-2- 3 Kasumi Minami-ku Hiroshima-city
TEL
082-257-5215
sueda@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kurosaki |
Organization
Hiroshima University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
1-2- 3 Kasumi Minami-ku Hiroshima-city
TEL
082-257-5215
Homepage URL
kurosakt@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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)
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
| 2018 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035267
