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Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

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ClinicalTrials.gov Identifier: NCT02248740
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 25, 2014
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Procedure: Ablation of the incompetent small saphenous vein Phase 4

Detailed Description:
Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The second most common cause is a refluxing or incompetent Small Saphenous Vein (SSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the SSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the SSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein: A Prospective Randomized Trial
Study Start Date : September 2008
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : March 29, 2017

Arm Intervention/treatment
Active Comparator: Radiofrequency Ablation

Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

Procedure: Ablation of the incompetent small saphenous vein
For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

Active Comparator: Laser Ablation

Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

Procedure: Ablation of the incompetent small saphenous vein
For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.




Primary Outcome Measures :
  1. Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment. [ Time Frame: At 10 years after treatment. ]

Secondary Outcome Measures :
  1. Incidence Rate of Acute Complications [ Time Frame: 1 and 6 weeks post intervention. ]

Other Outcome Measures:
  1. Incidence of Pain and Bruising [ Time Frame: During Intervention and post procedure recovery period in clinic, an expected average of 2 hours. ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248740


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Malcolm Sydnor, MD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02248740     History of Changes
Other Study ID Numbers: HM11844
First Posted: September 25, 2014    Key Record Dates
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019
Last Verified: September 2018
Keywords provided by Virginia Commonwealth University:
chronic venous insufficiency
varicose vein
small saphenous vein
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases