Venous DiseasePhase 2NCT02139085
Great Saphenous Vein Electrocoagulation
A Phase 2 study testing GSV Electrocoagulation and GSV Radiofrequency in people with Venous Disease and Varicose Veins, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Disease, Varicose Veins
- What is being tested?
- GSV Electrocoagulation and GSV Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV
Who cannot join
- Previous varicose vein surgery with removal of the GSV
- Pregnant women
- Patients in use of anticoagulants
- Known thrombophilia
- Presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin
- GSV diameter < 5mm and > 12 mm
- Previous deep vein thrombosis
- Peripheral arterial disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardilogia
São Paulo, São Paulo, 04012-909
Fabio H Rossi, PHD, 551150856000 ext. 4120, vascular369@me.com
Fabio H Rossi, HD
About this study
Official title: A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical results has never been studied before.
Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial.
Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when level of p <0.05.
Read the detailed description
All patients included in the study will be preoperatively examined to evaluate the severity of venous disease, using the CEAP classification, VCSS and AVVQ. They will undergo venous DS with the aim of investigating GSV insufficiency, its caliber and depth and presence of previous thrombophlebitis.
Patients will be randomized on the day of surgery with an electronic table of random numbers:
Group 1:Electrocoagulation treatment. Group 2: Radiofrequency treatment.
Patients and outcomes assessor will be blinded to the group of endovenous treatment.
- Conditions
- Venous Disease, Varicose Veins
- Being tested
- GSV Electrocoagulation, GSV Radiofrequency
- Keywords
- varicose veins, catheter ablation, Catheter Ablation, Electrical, Catheter Ablation, Radiofrequency
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSV ElectrocoagulationDevice
The energy source will be the Electrosurgical Generator (FX-Valley Lab; USA) and the GSV thermo ablation will be performed with 60 Watts per 10 seconds. The catheter and electrocoagulation device head will be pulled back in increments of 2 cm also to overlap the treatment sites.
GSV RadiofrequencyDevice
The second generation RF device (Closure FAST; Covidien, USA) will be used. The treatment component of the device is 7 cm in length and works with a segmental pullback protocol. Once the catheter is in position, activation of the generator delivers 20- seconds cycles of energy to the catheter tip, which heats the vein wall to 120 o C.
| Study group | Role | What they receive |
|---|---|---|
| GSV Electrocoagulation | Active comparator | GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds Receives: Device: GSV Electrocoagulation |
| GSV Radiofrequency | Active comparator | GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm Receives: Device: GSV Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSV occlusion
GSV occlusion verified by blinded DS operator
Measured: 3 months
GSV occlusion
GSV occlusion verified by blinded DS operator
Measured: 6 months
Secondary outcomes (7)
Pain VAS
Pain VAS by blinded Outcomes Assessor
Measured: 1 week
Post operative bruising
The bruised area traced manually, and the surface area estimated by placing the tracing on a square chart.
Assessment by blinded Outcomes Assessor.
Measured: 1 week
Post operative sensory abnormality
Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia.
Assessment by blinded Outcomes Assessor
Measured: 1 week
Venous Clinical Severity Score (VCSS)
Difference from baseline. Assessment by blinded Outcomes Assessor.
Measured: 6 months
Aberdeen Varicose Vein Questionnaire (AVVQ)
Difference from baseline. Assessment by blinded Outcomes Assessor.
Measured: 6 months
Deep Venous Thrombosis (DVT)
Presence of DVT verified by blinded DS operator
Measured: 1 week
Clinical Etiology Anatomy Pathophysiology (CEAP)
Difference from baseline. Assessment by blinded Outcomes Assessor.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia
- Investigators
- Fabio H Rossi, PHD, Principal investigator, Dante Pazzanese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139085
- Sponsor's protocol ID
- IDPC 2014
- Status last verified
- Aug 2014
- First submitted
- 12 May 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossi FH, Beteli CB, Zamorano MB, Silva LM. Immediate effects of endovascular electrocauterization in lower limb varicose veins. J Vasc Bras 11(3): 305-309, 2012.
Rossi FH, Izukawa NM, Silva DG, Chen J, Prakasan AK, Zamorano MM, Silva LM. Effects of electrocautery to provoke endovascular thermal injury. Acta Cir Bras. 2011 Oct;26(5):329-32. doi: 10.1590/s0102-86502011000500001.
PubMed 21952653
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
- ClinicalTrials.gov ID
- NCT02139085
- Acronym / sponsor ID
- IDPC 2014
- Conditions
- Venous Disease, Varicose Veins
- Keywords
- varicose veins, catheter ablation, Catheter Ablation, Electrical, Catheter Ablation, Radiofrequency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical results has never been studied before.
Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial.
Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when level of p <0.05.
Detailed description
All patients included in the study will be preoperatively examined to evaluate the severity of venous disease, using the CEAP classification, VCSS and AVVQ. They will undergo venous DS with the aim of investigating GSV insufficiency, its caliber and depth and presence of previous thrombophlebitis.
Patients will be randomized on the day of surgery with an electronic table of random numbers:
Group 1:Electrocoagulation treatment. Group 2: Radiofrequency treatment.
Patients and outcomes assessor will be blinded to the group of endovenous treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSV Electrocoagulation | Active comparator | Device: GSV ElectrocoagulationGSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds |
| GSV Radiofrequency | Active comparator | Device: GSV RadiofrequencyGSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV
Key exclusion criteria (8 listed)
- Previous varicose vein surgery with removal of the GSV
- Pregnant women
- Patients in use of anticoagulants
- Known thrombophilia
- Presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSV ElectrocoagulationThe energy source will be the Electrosurgical Generator (FX-Valley Lab; USA) and the GSV thermo ablation will be performed with 60 Watts per 10 seconds. The catheter and electrocoagulation device head will be pulled back in increments of 2 cm also to overlap the treatment sites. | Device | GSV Electrocoagulation |
| GSV RadiofrequencyThe second generation RF device (Closure FAST; Covidien, USA) will be used. The treatment component of the device is 7 cm in length and works with a segmental pullback protocol. Once the catheter is in position, activation of the generator delivers 20- seconds cycles of energy to the catheter tip, which heats the vein wall to 120 o C. | Device | GSV Radiofrequency |
Primary outcome
GSV occlusion
Time frame: 3 months
GSV occlusion verified by blinded DS operator
GSV occlusion
Time frame: 6 months
GSV occlusion verified by blinded DS operator
7 secondary outcomes
Pain VAS
Time frame: 1 week
Post operative bruising
Time frame: 1 week
Post operative sensory abnormality
Time frame: 1 week
Venous Clinical Severity Score (VCSS)
Time frame: 6 months
Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: 6 months
Deep Venous Thrombosis (DVT)
Time frame: 1 week
Clinical Etiology Anatomy Pathophysiology (CEAP)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
- BackgroundRossi FH, Beteli CB, Zamorano MB, Silva LM. Immediate effects of endovascular electrocauterization in lower limb varicose veins. J Vasc Bras 11(3): 305-309, 2012.
- Background: PubMed 21952653Rossi FH, Izukawa NM, Silva DG, Chen J, Prakasan AK, Zamorano MM, Silva LM. Effects of electrocautery to provoke endovascular thermal injury. Acta Cir Bras. 2011 Oct;26(5):329-32. doi: 10.1590/s0102-86502011000500001.
- free articleLink provided by the sponsor.
- free articleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio H Rossi, PHD principal investigator
Dante Pazzanese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSV Electrocoagulation and GSV Radiofrequency in people with Venous Disease and Varicose Veins, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio H Rossi, PHD (551142276668, vascular369@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSV occlusion (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.