None listed
Conditions
Interventions
Medical Device : The procedure was performed under ultrasound guidance, starting with local anesthesia at the distal end of the great saphenous vein (GSV) followed by catheter insertion. For each inje
simultaneously, the catheter was retracted by a specified distance immediately after injection, and manual compression was applied to the site. Following the protocol, compression was maintained for 3
both the test and control groups received the intervention according to the identical protocol described above.
Sponsors
Engain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for participation in this clinical trial. 1. Male or female subjects aged 19 to 70 years, inclusive. 2. Subjects with confirmed great saphenous vein reflux of greater than or equal to 0.5 seconds on duplex ultrasound. 3. Subjects classified as C2 (symptomatic) to C4b according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification in the limb requiring the procedure. 3-1. Subjects with one or more of the following symptoms related to the target vein (great saphenous vein) in the limb requiring the procedure: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, or swelling. 4.Subjects with a target vein (great saphenous vein) diameter greater than or equal to 3 mm and less than or equal to 12 mm, as measured by duplex ultrasound in the standing position. 5. Subjects who are ambulatory without assistance. 6. Subjects who voluntarily decided to participate in this clinical trial and provided signed written informed consent. 7. Subjects who are willing and able to comply with the clinical trial protocol.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria were excluded from participation in this clinical trial. 1. Subjects diagnosed with peripheral arterial disease (PAD) with an ankle-brachial index (ABI) less than or equal to 0.9, and who present with symptoms related to peripheral arterial disease at the time of screening. (Symptoms include pain in the lower extremities, muscle cramps, intermittent claudication, paresthesia, etc.) 2. Subjects with a target vein (great saphenous vein) diameter greater than 12 mm as confirmed by duplex ultrasound. 3. Subjects in whom catheter placement is considered impossible due to the tortuosity of the target vein. 4. Subjects with a history of surgery or procedures for venous disease (excluding spider veins) in the limb requiring the procedure (e.g., phlebectomy, high ligation and stripping, radiofrequency ablation, laser venous ablation, etc.). 5. Subjects requiring treatment for varicose veins in the contralateral or ipsilateral lower extremity within 3 months after the procedure. 6. Subjects judged to require daily administration of analgesics (opioids, non-steroidal anti-inflammatory drugs (NSAIDs), or acetaminophen) during the clinical trial period for the management of pain related to saphenous vein reflux. (Opioid analgesics include morphine, oxycodone, hydrocodone, hydromorphone, fentanyl, tramadol, methadone, meperidine, etc.; NSAIDs include aspirin, ketorolac, diclofenac, ibuprofen, naproxen, nabumetone, etc.) 7. Subjects regularly taking anticoagulants (Warfarin, Heparin) for an underlying condition and who require continuous administration during the clinical trial period. 8. Subjects with any of the following accompanying diseases or medical histories at the time of screening: ? Coagulation disorders (hemophilia, disseminated intravascular coagulation, etc.) ? Superficial thrombophlebitis in the target vein (great saphenous vein) ? Thrombophlebitis migrans ? Deep vein thrombosis or pulmonary embolism ? Malignant tumors (However, subjects with a history of non-melanoma skin cancer (squamous cell carcinoma, basal cell carcinoma) were eligible if they had been appropriately treated) ? Local infection of the limb requiring the procedure or systemic infection (sepsis, etc.) 9. Subjects with a history of hypersensitivity to cyanoacrylate adhesives. 10. Subjects with a history of hypersensitivity to local anesthetics, such as lidocaine including epinephrine. 11. Subjects who are pregnant or breastfeeding. 12. Women of childbearing potential who do not agree to use medically accepted contraceptive methods during the clinical trial period. (Medically accepted methods include hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, double-barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges), or a single barrier method used in combination with spermicide.) 13. Subjects currently participating in another clinical trial or those who have participated in another clinical trial within 30 days of the screening date. 14. Cases where the investigator judges that participation is inappropriate due to concerns about ethical issues or potential influence on the clinical trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with complete occlusion of the target vein | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Venous Clinical Severity Score (VCSS);Change from baseline in Aberdeen Varicose Vein Questionnaire (AVVQ) score;Procedure-related pain score (Numeric Rating Scale, NRS);Ecchymosis score at the treatment site;Incidence of treatment-emergent adverse events;Incidence of predefined major adverse events;Incidence of deep vein thrombosis;Incidence of pulmonary embolism;Incidence and grade distribution of adhesive-related thrombosis;Percentage of subjects with complete occlusion of the target vein;Distribution of subjects by Clinical–Etiological–Anatomical–Pathophysiological (CEAP) clinical class | — |
Countries
Korea, Republic of
Contacts
Public ContactJang Yong Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed