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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038838
Receipt No. 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 2019/12/17

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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 Affairs
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Email 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 Affairs, Post Market Surveillance Division
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Homepage URL
Email aki.umetsu@medtronic.com

Sponsor
Institute Covidien Japan Inc.
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2019 Year 12 Month 10 Day
Last modified on
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044045

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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