Varicose VeinsTEThANCT06669260
Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins
An observational study of Varicose Veins and Quality of Life, run by Nara Medeiros Cunha de Melo Vasconcelos.
Trial summary
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicose Veins, Quality of Life, Laser
- What is being tested?
- TEThA technique
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2024to 22 Jul 2025
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP
Who may be able to join
- Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
Who cannot join
- Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).
Read the detailed description
Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.
- Conditions
- Varicose Veins, Quality of Life, Laser
- Being tested
- TEThA technique
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEThA techniqueProcedure or surgery
Patient in an orthostatic position, previously marked varicose veins will be punctured with a tracing adjacent to them, surrounding their edges. Applying an augmented reality device and Doppler ultrasound (Doppler USG), the marking will be complemented in the supine position. These punctures will in turn be carried out using the TEThA technique - endovenous thermoablation of tributary veins by means of transfixation - and will be done sequentially as they are treated one by one with endo- and perivenous thermoablation under generous tumescence with 0.08% lidocaine in saline solution. The laser used to treat the tributary veins will also be 1470 nm and will be fired as the fiber is removed at a speed of 1 mm/sec and power ranging from 5 to 7 watts.
| Study group | Role | What they receive |
|---|---|---|
| TEThA technique | TEThA technique Receives: Procedure: TEThA technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
AVVQ is an easy-to-administer, self-administered instrument, it consists of 3 dimensions, which are physical, sociofunctional and psychological. It is interpreted through a score, which can vary between 0 and 100, with 0 representing no evidence of varicose veins and 100 the most serious problem associated with varicose veins.
Measured: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.
Measured: Timepoints post-procedire: 1 month, 3 months, 6 months
Secondary outcomes (7)
Hyperpigmentation
Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)
Measured: Baseline, 30 days and 180 days
Presence of induration
Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)
Measured: 30 days and 180 days
Presence of Paresthesia
Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique
Measured: 30 days and 180 days
Skin burns
Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique
Measured: 7 days
Lymphedema
Presence or absence of lymphedema diagnosed by exam of lymphoscintigraphy in the limb treated by endovenous laser TEThA technique
Measured: 30 days and 180 days
Sclerothrombus
Presence of Sclerothrombus (US doppler)
Measured: 7 days
Complementary treatment
Percentage of participants with residual veins
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start21 Nov 2024 (estimated)
- Primary completion22 Jul 2025 (estimated)
- Study completion22 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nara Medeiros Cunha de Melo Vasconcelos
- Sponsor type
- University, hospital or other
- Collaborators
- Gabriela de Oliveira Buril, Marcelo Halfen Grill
- Responsible party
- Sponsor-investigator, Nara Medeiros Cunha de Melo Vasconcelos, Science Valley Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669260
- Sponsor's protocol ID
- TEThA
- Acronym
- TEThA
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salim S, Machin M, Patterson BO, Onida S, Davies AH. Global Epidemiology of Chronic Venous Disease: A Systematic Review With Pooled Prevalence Analysis. Ann Surg. 2021 Dec 1;274(6):971-976. doi: 10.1097/SLA.0000000000004631.
PubMed 33214466Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.
PubMed 32113854De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
PubMed 35027279Vasconcelos NMCM, Kumakura HS, Grill MH, Silva MCE. Treatment of the small saphenous vein and tributary veins with endolaser associated with ultrasound-guided foam in a patient with post-thrombotic syndrome: presenting the TEThA technique. J Vasc Bras. 2024 Nov 29;23:e20230142. doi: 10.1590/1677-5449.202301422. eCollection 2024.
PubMed 39629276
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
- ClinicalTrials.gov ID
- NCT06669260
- Acronym / sponsor ID
- TEThA / TEThA
- Conditions
- Varicose Veins, Quality of Life, Laser
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nara Medeiros Cunha de Melo VasconcelosUniversity, hospital or other
- Collaborators
- Gabriela de Oliveira Buril, Marcelo Halfen Grill
- Study start
- 21 Nov 2024 (estimated)
- Primary completion
- 22 Jul 2025 (estimated)
- Study completion
- 22 Jul 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- 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.
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).
Detailed description
Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEThA technique | – | Procedure: TEThA techniqueTEThA technique |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with tributary veins bigger than 2mm, presenting saphenous truncal incompetency scoring from C2 to C6 in CEAP
Key inclusion criteria (1 listed)
- Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
Key exclusion criteria (1 listed)
- Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
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 |
|---|---|---|
| TEThA techniquePatient in an orthostatic position, previously marked varicose veins will be punctured with a tracing adjacent to them, surrounding their edges. Applying an augmented reality device and Doppler ultrasound (Doppler USG), the marking will be complemented in the supine position. These punctures will in turn be carried out using the TEThA technique - endovenous thermoablation of tributary veins by means of transfixation - and will be done sequentially as they are treated one by one with endo- and perivenous thermoablation under generous tumescence with 0.08% lidocaine in saline solution. The laser used to treat the tributary veins will also be 1470 nm and will be fired as the fiber is removed at a speed of 1 mm/sec and power ranging from 5 to 7 watts. | Procedure or surgery | TEThA technique |
Primary outcome
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
Time frame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
AVVQ is an easy-to-administer, self-administered instrument, it consists of 3 dimensions, which are physical, sociofunctional and psychological. It is interpreted through a score, which can vary between 0 and 100, with 0 representing no evidence of varicose veins and 100 the most serious problem associated with varicose veins.
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time frame: Timepoints post-procedire: 1 month, 3 months, 6 months
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.
7 secondary outcomes
Hyperpigmentation
Time frame: Baseline, 30 days and 180 days
Presence of induration
Time frame: 30 days and 180 days
Presence of Paresthesia
Time frame: 30 days and 180 days
Skin burns
Time frame: 7 days
Lymphedema
Time frame: 30 days and 180 days
Sclerothrombus
Time frame: 7 days
Complementary treatment
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 33214466Salim S, Machin M, Patterson BO, Onida S, Davies AH. Global Epidemiology of Chronic Venous Disease: A Systematic Review With Pooled Prevalence Analysis. Ann Surg. 2021 Dec 1;274(6):971-976. doi: 10.1097/SLA.0000000000004631.
- Background: PubMed 32113854Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27.
- Background: PubMed 35027279De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
- Background: PubMed 39629276Vasconcelos NMCM, Kumakura HS, Grill MH, Silva MCE. Treatment of the small saphenous vein and tributary veins with endolaser associated with ultrasound-guided foam in a patient with post-thrombotic syndrome: presenting the TEThA technique. J Vasc Bras. 2024 Nov 29;23:e20230142. doi: 10.1590/1677-5449.202301422. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Quality of Life, run by Nara Medeiros Cunha de Melo Vasconcelos.
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 1 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Eduardo Ramacciotti, MD, PhD (+55 11 4040-8670, eduardoramacciotti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ) (time frame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 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 NCT06669260, which also lists 4 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 1 Nov 2024.