UMIN-CTR Clinical Trial

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
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 Medical 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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044045