Chronic Venous Insufficiency Clinical Trial
Official title:
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein: A Prospective Randomized Trial
Verified date | September 2018 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.
Status | Terminated |
Enrollment | 36 |
Est. completion date | March 29, 2017 |
Est. primary completion date | March 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with symptomatic chronic venous insufficiency. - Patients in whom endovenous thermal ablation is clinically indicated. - Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices). - Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow in the saphenous vein >0.5 seconds after calf compression or while standing. Exclusion Criteria: - Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures). - Have a history of Deep Venous Thrombosis (DVT). - Have a history of hypercoaguability disorder. - Are pregnant or breastfeeding. - Are nonambulatory. |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of Pain and Bruising | Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10. Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators. |
During Intervention and post procedure recovery period in clinic, an expected average of 2 hours. | |
Primary | Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment. | At 10 years after treatment. | ||
Secondary | Incidence Rate of Acute Complications | 1 and 6 weeks post intervention. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02462096 -
A Feasibility Study of the ReLeaf Catheter System
|
N/A | |
Enrolling by invitation |
NCT05504070 -
Venclose digiRF System Post Market Study
|
N/A | |
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Recruiting |
NCT05622500 -
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease
|
N/A | |
Completed |
NCT03283800 -
Copper Impact on Venous Insufficiency and Lipodermatosclerosis
|
N/A | |
Completed |
NCT02236338 -
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
|
Phase 4 | |
Completed |
NCT01501188 -
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
|
Phase 1 | |
Recruiting |
NCT05982405 -
Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT05383469 -
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT06238791 -
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
|
||
Withdrawn |
NCT02559427 -
SPA Therapy in the Treatment of Sleep Apnea Syndrome
|
N/A | |
Completed |
NCT02346058 -
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
|
Phase 4 | |
Active, not recruiting |
NCT05926830 -
Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
|
N/A | |
Withdrawn |
NCT05047302 -
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada
|
N/A | |
Active, not recruiting |
NCT04339075 -
Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
|
||
Active, not recruiting |
NCT04580160 -
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
|
N/A | |
Not yet recruiting |
NCT02927483 -
Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency
|
Phase 3 | |
Completed |
NCT02015221 -
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
|
N/A | |
Completed |
NCT02050061 -
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
|
N/A | |
Completed |
NCT01432795 -
Practicability of Gliding Aids for Medical Compression Stockings
|
Phase 4 |