Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT03835559
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins
Sponsor:
Kyung Hee University Hospital at Gangdong
Organization:
Study Overview
Official Title:
Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
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:
CASS
Brief Summary:
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
Detailed Description:
Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: