Post Market Surveillance of the VenaSeal(TM) Closure System

Post Market Surveillance of the VenaSeal(TM) Closure System - Post Market Surveillance of the VenaSeal(TM) Closure System

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038838

Enrollment

120

Registered

2019-12-10

Start date

2019-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary varicose vein of lower extremity

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
-Ecchymosis -Vein occlusion(Complete vein occlusion)	—

Countries

Japan

Contacts

Public ContactAki Umetsu

Medtronic Japan Co.,Ltd. Clinical Medical Affairs, Post Market Surveillance Division

aki.umetsu@medtronic.com03-6776-0007

Outcome results