<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04479956</url>
  </required_header>
  <id_info>
    <org_study_id>R.20.06.905 - 2020/06/18</org_study_id>
    <nct_id>NCT04479956</nct_id>
  </id_info>
  <brief_title>Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence</brief_title>
  <official_title>Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The authors will aim to compare microwave therapy with other lines of management&#xD;
      radio-frequency ablation, Laser ablation and surgical ligation; regarding time to recurrence&#xD;
      rate, ulcer-free time, and health-related quality of life. In a randomized controlled&#xD;
      study,The study will be conducted at the department of vascular surgery in Mansoura&#xD;
      university hospitals&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION:&#xD;
&#xD;
      Chronic venous disease (CVD) is one of the most common pathologies in the general population&#xD;
      of adults in both industrialized and developing countries.1 the most severe form of CVD is&#xD;
      venous ulceration with an overall prevalence of about 1 % in the adult population, which&#xD;
      increases with age and is more common in women and obese patients. Venous ulcers&#xD;
      significantly impair quality of life, and their treatment places a heavy financial burden&#xD;
      upon healthcare systems. Varicose veins (VVS) is a common disease in adults, and VVS without&#xD;
      skin changes are present in about 20% of the population, while active ulcers are found in&#xD;
      0.5%. The traditional surgical treatment of VVS is high ligation of the great saphenous vein&#xD;
      (GSV), axial stripping and phlebotomy, but the postoperative clinical recurrence is as high&#xD;
      as 60%.&#xD;
&#xD;
      Recently, minimally invasive techniques, such as endovenous laser ablation (EVLA) and&#xD;
      radiofrequency ablation (RFA), have become widely used for the treatment of VVS. Several&#xD;
      reports have shown Several reports have shown that endovenous techniques are as effective as&#xD;
      traditional procedures.&#xD;
&#xD;
      Endovenous Microwave Ablation (EMA) for the treatment of VVS differs from the other&#xD;
      endovenous methods, and no specific dose regime has been established for this system. Thus,&#xD;
      it is unclear if EMA is more or less effective than conventional surgery, or whether it has&#xD;
      any additional benefits. In this study, we compared the clinical outcome of high ligation and&#xD;
      stripping (HLS) with EMA. Postoperative quality of life (QoL) analysis was assessed using the&#xD;
      Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS).&#xD;
&#xD;
      Aim of the work: Aimed to compare microwave therapy with other lines of management&#xD;
      radiofrequency ablation, Laser ablation and surgical ligation; regarding time to recurrence&#xD;
      rate, ulcer-free time, and health-related quality of life.&#xD;
&#xD;
      Patients and methods Study location: The study will be conducted at the department of&#xD;
      vascular surgery in Mansoura university hospitals Type of study: Randomized controlled&#xD;
      Prospective study Study duration: 2 years: 2019-2021 Sample size: It will include all&#xD;
      patients presented to our department fulfilling the inclusion criteria.&#xD;
&#xD;
      Study population: The study will be conducted in patients with Incompetent Great saphenous&#xD;
      vein&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      • Primary symptomatic VVS (CEAP, C3eC6), sapheno-femoral junction (SFJ) incompetence, GSV&#xD;
      reflux from the groin to below the knee&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      • Exclusion criteria included a history of venous surgery, suspected or proven deep venous&#xD;
      thrombosis, reflux of deep veins to distal limb, duplication of GSV, and patients' refusal to&#xD;
      participate in the trial.&#xD;
&#xD;
      Consent: Patients after signing informed consent that possible complication from the&#xD;
      procedure ought to happen and what are the alternatives.&#xD;
&#xD;
      Data collection: The demographics, Symptoms and preoperative clinical data will be collected&#xD;
      History Data: included patient's demographics, underlying medical conditions, any previous&#xD;
      associated morbidity.&#xD;
&#xD;
      Examination: Venous examinations. Laboratory: Blood picture, Blood sugar level, Kidney&#xD;
      functions, Liver functions and Coagulation profile.&#xD;
&#xD;
      Imaging: Duplex US Method of Randomization: Computer based Therapies Surgical group.&#xD;
      Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The&#xD;
      trunk of GSV and the tributaries will be ligated and divided. The GSV will be removed using a&#xD;
      pin-stripper, and all varices and incompetent perforators will be removed by phlebectomy.&#xD;
&#xD;
      Microwave group. The microwave treating wire (Microwave Intracavity Coagulation System;&#xD;
      Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached&#xD;
      the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV&#xD;
      will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s,&#xD;
      with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80&#xD;
      J/cm); the treatment parameters will be based on a previous report. Tumescence will be used&#xD;
      in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and&#xD;
      20 mL 0.5% levobupivacaine in 1 L 0.9% saline.&#xD;
&#xD;
      Laser ablation group: Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted&#xD;
      into the abnormal vein via a small skin puncture.using 1470 nm laser and a &quot;radial&quot; fiber for&#xD;
      less discomfort. Two weeks later the &quot;branch vessels&quot; have reduced in size Radiofrequency&#xD;
      ablation group: inserts a small catheter into the diseased vein through a small incision,&#xD;
      using ultrasound guidance for an accurate and live view. Consistent and uniform heat is&#xD;
      delivered to contract the collagen in the vein walls, causing them to collapse and close.&#xD;
      After the vein is closed the treated vein is gradually absorbed into surrounding tissue&#xD;
&#xD;
      Follow up&#xD;
&#xD;
      Criteria for technical success will be:&#xD;
&#xD;
        1. Closed or absent GSV with lack of flow&#xD;
&#xD;
        2. A re-canalized GSV or treatment failure will be defined as an open segment of the&#xD;
           treated vein segment of &gt;10 cm in length.&#xD;
&#xD;
        3. All patients will be followed as outpatients up at 1, 3, 6, 12, and 24 months after&#xD;
           surgery.&#xD;
&#xD;
        4. The operation time, number of incisions, intraoperative blood loss (determined by the&#xD;
           swabs weighed pre and postoperatively)&#xD;
&#xD;
        5. Recurrence of varicosities will be recorded, as well as any complications.&#xD;
&#xD;
      The criteria for assessment:&#xD;
&#xD;
        1. Ecchymosis was confirmed 72 h after operation when the lividity and congestion area was&#xD;
           &gt;1 cm2 in the affected limbs.&#xD;
&#xD;
        2. Skin burns were identified 72 h after operation when the skin was red and oedematous&#xD;
           according to the criteria for burns.&#xD;
&#xD;
        3. Recurrence was defined by both duplex ultrasound and the clinical examination. A&#xD;
           varicose vein that had not been observed before or previously been marked by the patient&#xD;
           on the AVVQ form was considered to be a recurrent varicose vein (owing to&#xD;
           neo-vascularization or dilation of pre-existing veins).&#xD;
&#xD;
        4. Sensory impairment (numbness) that occurred around incisions was recorded based on the&#xD;
           patient's history and physical examination.&#xD;
&#xD;
      QoL assessment The diseased relation effect on QoL was determined using the AVVQ (Chinese&#xD;
      version), which assessed the specific effect on QoL and was scored from 0 (no effect of VVS&#xD;
      on QoL) to a theoretical maximum of 100.8 The VCSS (Chinese version) was also completed (for&#xD;
      the VCSS, 0 represents no significant venous disease and 30 is the maximum score), which is a&#xD;
      valid sensitive and responsive measure of the severity of VVS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 18, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized controlled Prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Computer Based</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Great Saphenous vein patency</measure>
    <time_frame>6 months</time_frame>
    <description>Lack of flow or closed great saphenous vein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operation Time</measure>
    <time_frame>intraoperative</time_frame>
    <description>The time of the whole procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence varicose vein</measure>
    <time_frame>12 Months</time_frame>
    <description>varicose veins reappear again after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effect of the procedure</measure>
    <time_frame>12 Months</time_frame>
    <description>Thrombophlebitis, infection or blood loss</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Varicose Veins</condition>
  <arm_group>
    <arm_group_label>Surgical Ligation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The trunk of GSV and the tributaries will be ligated and divided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microwave group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The microwave treating wire (Microwave Intracavity Coagulation System; Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s, with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80 J/cm); the treatment parameters will be based on a previous report. Tumescence will be used in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L 0.9% saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted into the abnormal vein via a small skin puncture.using 1470 nm laser and a &quot;radial&quot; fiber for less discomfort. Two weeks later the &quot;branch vessels&quot; have reduced in size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>inserts a small catheter into the diseased vein through a small incision, using ultrasound guidance for an accurate and live view. Consistent and uniform heat is delivered to contract the collagen in the vein walls, causing them to collapse and close. After the vein is closed the treated vein is gradually absorbed into surrounding tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Varicose vein surgery</intervention_name>
    <description>sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee</description>
    <arm_group_label>Laser ablation group</arm_group_label>
    <arm_group_label>Microwave group</arm_group_label>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
    <arm_group_label>Surgical Ligation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary symptomatic VVS (CEAP, C3 , C6),&#xD;
&#xD;
          -  Sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the&#xD;
             knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of venous surgery, suspected or proven deep venous thrombosis,&#xD;
&#xD;
          -  Reflux of deep veins to distal limb&#xD;
&#xD;
          -  Duplication of GSV&#xD;
&#xD;
          -  Patients' refusal to participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mansoura</name>
      <address>
        <city>Mansoura</city>
        <state>Mansoura University</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>0502202876</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Mansoura UH Hospitals</last_name>
      <phone>050 2202750</phone>
      <phone_ext>0200</phone_ext>
      <email>muh@mans.edu.eg</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Mansoura University Hospital</name>
      <address>
        <city>Mansoura</city>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mosaad A. Soliman, PhD</last_name>
      <phone>01001535711</phone>
      <phone_ext>002</phone_ext>
      <email>soliman_mosaad@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04479956
org study id: R.20.06.905 - 2020/06/18
nct id: NCT04479956
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The authors will aim to compare microwave therapy with other lines of management
      radio-frequency ablation, Laser ablation and surgical ligation; regarding time to recurrence
      rate, ulcer-free time, and health-related quality of life. In a randomized controlled
      study,The study will be conducted at the department of vascular surgery in Mansoura
      university hospitals
INTRODUCTION:

      Chronic venous disease (CVD) is one of the most common pathologies in the general population
      of adults in both industrialized and developing countries.1 the most severe form of CVD is
      venous ulceration with an overall prevalence of about 1 % in the adult population, which
      increases with age and is more common in women and obese patients. Venous ulcers
      significantly impair quality of life, and their treatment places a heavy financial burden
      upon healthcare systems. Varicose veins (VVS) is a common disease in adults, and VVS without
      skin changes are present in about 20% of the population, while active ulcers are found in
      0.5%. The traditional surgical treatment of VVS is high ligation of the great saphenous vein
      (GSV), axial stripping and phlebotomy, but the postoperative clinical recurrence is as high
      as 60%.

      Recently, minimally invasive techniques, such as endovenous laser ablation (EVLA) and
      radiofrequency ablation (RFA), have become widely used for the treatment of VVS. Several
      reports have shown Several reports have shown that endovenous techniques are as effective as
      traditional procedures.

      Endovenous Microwave Ablation (EMA) for the treatment of VVS differs from the other
      endovenous methods, and no specific dose regime has been established for this system. Thus,
      it is unclear if EMA is more or less effective than conventional surgery, or whether it has
      any additional benefits. In this study, we compared the clinical outcome of high ligation and
      stripping (HLS) with EMA. Postoperative quality of life (QoL) analysis was assessed using the
      Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS).

      Aim of the work: Aimed to compare microwave therapy with other lines of management
      radiofrequency ablation, Laser ablation and surgical ligation; regarding time to recurrence
      rate, ulcer-free time, and health-related quality of life.

      Patients and methods Study location: The study will be conducted at the department of
      vascular surgery in Mansoura university hospitals Type of study: Randomized controlled
      Prospective study Study duration: 2 years: 2019-2021 Sample size: It will include all
      patients presented to our department fulfilling the inclusion criteria.

      Study population: The study will be conducted in patients with Incompetent Great saphenous
      vein

      Inclusion criteria:

      • Primary symptomatic VVS (CEAP, C3eC6), sapheno-femoral junction (SFJ) incompetence, GSV
      reflux from the groin to below the knee

      Exclusion criteria:

      • Exclusion criteria included a history of venous surgery, suspected or proven deep venous
      thrombosis, reflux of deep veins to distal limb, duplication of GSV, and patients' refusal to
      participate in the trial.

      Consent: Patients after signing informed consent that possible complication from the
      procedure ought to happen and what are the alternatives.

      Data collection: The demographics, Symptoms and preoperative clinical data will be collected
      History Data: included patient's demographics, underlying medical conditions, any previous
      associated morbidity.

      Examination: Venous examinations. Laboratory: Blood picture, Blood sugar level, Kidney
      functions, Liver functions and Coagulation profile.

      Imaging: Duplex US Method of Randomization: Computer based Therapies Surgical group.
      Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The
      trunk of GSV and the tributaries will be ligated and divided. The GSV will be removed using a
      pin-stripper, and all varices and incompetent perforators will be removed by phlebectomy.

      Microwave group. The microwave treating wire (Microwave Intracavity Coagulation System;
      Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached
      the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV
      will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s,
      with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80
      J/cm); the treatment parameters will be based on a previous report. Tumescence will be used
      in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and
      20 mL 0.5% levobupivacaine in 1 L 0.9% saline.

      Laser ablation group: Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted
      into the abnormal vein via a small skin puncture.using 1470 nm laser and a "radial" fiber for
      less discomfort. Two weeks later the "branch vessels" have reduced in size Radiofrequency
      ablation group: inserts a small catheter into the diseased vein through a small incision,
      using ultrasound guidance for an accurate and live view. Consistent and uniform heat is
      delivered to contract the collagen in the vein walls, causing them to collapse and close.
      After the vein is closed the treated vein is gradually absorbed into surrounding tissue

      Follow up

      Criteria for technical success will be:

        1. Closed or absent GSV with lack of flow

        2. A re-canalized GSV or treatment failure will be defined as an open segment of the
           treated vein segment of >10 cm in length.

        3. All patients will be followed as outpatients up at 1, 3, 6, 12, and 24 months after
           surgery.

        4. The operation time, number of incisions, intraoperative blood loss (determined by the
           swabs weighed pre and postoperatively)

        5. Recurrence of varicosities will be recorded, as well as any complications.

      The criteria for assessment:

        1. Ecchymosis was confirmed 72 h after operation when the lividity and congestion area was
           >1 cm2 in the affected limbs.

        2. Skin burns were identified 72 h after operation when the skin was red and oedematous
           according to the criteria for burns.

        3. Recurrence was defined by both duplex ultrasound and the clinical examination. A
           varicose vein that had not been observed before or previously been marked by the patient
           on the AVVQ form was considered to be a recurrent varicose vein (owing to
           neo-vascularization or dilation of pre-existing veins).

        4. Sensory impairment (numbness) that occurred around incisions was recorded based on the
           patient's history and physical examination.

      QoL assessment The diseased relation effect on QoL was determined using the AVVQ (Chinese
      version), which assessed the specific effect on QoL and was scored from 0 (no effect of VVS
      on QoL) to a theoretical maximum of 100.8 The VCSS (Chinese version) was also completed (for
      the VCSS, 0 represents no significant venous disease and 30 is the maximum score), which is a
      valid sensitive and responsive measure of the severity of VVS.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized controlled Prospective study
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Computer Based
measure: Great Saphenous vein patency
time frame: 6 months
description: Lack of flow or closed great saphenous vein
measure: Operation Time
time frame: intraoperative
description: The time of the whole procedure
measure: Recurrence varicose vein
time frame: 12 Months
description: varicose veins reappear again after the operation
measure: Adverse effect of the procedure
time frame: 12 Months
description: Thrombophlebitis, infection or blood loss
arm group label: Surgical Ligation
arm group type: Experimental
description: Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The trunk of GSV and the tributaries will be ligated and divided.
arm group label: Microwave group
arm group type: Experimental
description: The microwave treating wire (Microwave Intracavity Coagulation System; Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s, with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80 J/cm); the treatment parameters will be based on a previous report. Tumescence will be used in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L 0.9% saline.
arm group label: Laser ablation group
arm group type: Experimental
description: Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted into the abnormal vein via a small skin puncture.using 1470 nm laser and a "radial" fiber for less discomfort. Two weeks later the "branch vessels" have reduced in size
arm group label: Radiofrequency ablation group
arm group type: Experimental
description: inserts a small catheter into the diseased vein through a small incision, using ultrasound guidance for an accurate and live view. Consistent and uniform heat is delivered to contract the collagen in the vein walls, causing them to collapse and close. After the vein is closed the treated vein is gradually absorbed into surrounding tissue.
intervention type: Procedure
intervention name: Varicose vein surgery
description: sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee
arm group label: Laser ablation group
arm group label: Microwave group
arm group label: Radiofrequency ablation group
arm group label: Surgical Ligation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Varicose Veins
sharing ipd: No