UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038838 |
|---|---|
| Receipt number | R000044045 |
| Scientific Title | Post Market Surveillance of the VenaSeal(TM) Closure System |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2022/06/12 22:30:54 |
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Basic information
Public title
Post Market Surveillance of the VenaSeal(TM) Closure System
Acronym
Post Market Surveillance of the VenaSeal(TM) Closure System
Scientific Title
Post Market Surveillance of the VenaSeal(TM) Closure System
Scientific Title:Acronym
Post Market Surveillance of the VenaSeal(TM) Closure System
Region
| Japan |
Condition
Condition
primary varicose vein of lower extremity
Classification by specialty
| Cardiology | Vascular surgery | Orthopedics |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this Surveillance is to ensure the safety and effectiveness of the VenaSeal(TM) Closure System in patients who are treated with the product under the actual post-market use conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse Events
1)Serious adverse events occurred during the index procedure and within 1 year post-procedure
2)Procedure related adverse events at all target veins during the index procedure and within 1 year post-procedure
3)The product related adverse events at all target veins during the index procedure and within 1year post-procedure
Adverse events to be carefully observed in specific are as follows.
-Phlebitis (Treatment zone, Non-treatment zone)
-Symptomatic superficial vein thrombosis
-Symptomatic deep venous thrombosis (DVT)
-Symptomatic pulmonary embolism (PE)
-Cellulitis or infection along treatment length (except for access site)
-Paresthesia (Nervous disorder)
-Skin ulcers
-Allergic reaction
Key secondary outcomes
-Ecchymosis
-Vein occlusion(Complete vein occlusion)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The product is indicated for patient with primary varicose vein of lower extremity without deep venous occlusion (or obstruction) in the saphenous vein diameter 12mm or less of GSV and SSV.
Key exclusion criteria
N/A
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kikuchi |
Organization
Covidien Japan Inc.
Division name
Clinical Medical Affairs
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
akira.kikuchi@medtronic.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Umetsu |
Organization
Medtronic Japan Co.,Ltd.
Division name
Clinical Medical Affairs, Post Market Surveillance Division
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
Homepage URL
aki.umetsu@medtronic.com
Sponsor or person
Institute
Covidien Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2019 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2019 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044045
| 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 |
