Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT01197833
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2010-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
017
Brief Summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: