Varicose VeinsPhase 4LAMANCT02627846
Laser Ablation Versus Mechanochemical Ablation Trial
A Phase 4 study testing EVLA, ClariVein® and Lidocaine with 1:200,000 epinephrine solution in people with Varicose Veins, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- EVLA, ClariVein® and Lidocaine with 1:200,000 epinephrine solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2015to 4 Sep 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
- Clinical grades C2-C6 on the CEAP system
- Superficial axial incompetence with proposed treatment lengths of at least 10cm
- Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
- Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language
Who cannot join
- One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
- Unwilling or inability to comply with the requirements for follow-up visits
- Known allergy to medications or dressings used in the treatment
- Known right to left circulatory shunt
- Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
- Pelvic vein insufficiency
Show all 12Show fewer
- Active or recent thrombophlebitis (within 6 weeks)
- Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
- Pregnancy or breast feeding
- Active malignancy
- Immobility
- Involvement in other CTIMP trials within the last 6 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull and East Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ
About this study
Official title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.
Read the detailed description
Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat.
Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat such as endovenous laser ablation (EVLA) should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort.
Since NICE guidelines, a new treatment technique known as mechanochemical ablation (MOCA) using ClariVein® has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment technique aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same.
This trial will randomly allocate volunteer patients to have their varicose veins treated with either EVLA or MOCA. The investigators will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results. Long term follow-ups will occur at 5 and 10 years.
- Conditions
- Varicose Veins
- Being tested
- EVLA, ClariVein®, Lidocaine with 1:200,000 epinephrine solution, Sodium Bicarbonate, Sodium Tetradecyl Sulphate
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLADevice
Also called Endovenous Laser Ablation
1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. The EVLA fibre is introduced into the vein using the Seldinger technique and its tip will be positioned under duplex ultrasound (DUS). Then tumescent anaesthetic, made of a solution of 100ml of 1% Lidocaine with 1:200,000 epinephrine in 900ml of 0.9% Sodium Chloride and buffered to pH 7.4 with 10ml of 8.4% Sodium Bicarbonate, will be infiltrated around the target axial vein under DUS using a spinal needle and a peristaltic pump. Following deployment of appropriate laser safety precautions, the laser energy will be delivered via the fibre. The wavelength used is 1470nm, with NeverTouch Gold-Tip fibre, at 10W power. This laser light energy is converted into heat inducing a permanent, non-thrombotic occlusion.
ClariVein®Device
Also called Mechanochemical Ablation
1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. MOCA is performed by a device called ClariVein® (Vascular Insights, UK) which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. The sclerosant will be Sodium Tetradecyl Sulphate (STS), marketed as Fibrovein. Concentration of 1.5% Fibrovein will be used, and maximum of 12ml.
Lidocaine with 1:200,000 epinephrine solutionDrug
Also called Lignocaine with 1:200,000 adrenaline solution
It is used as local anaesthetic given via subcutaneous injection, so that the skin is numb prior to the introduction of either endovenous laser ablation or mechenochemical ablation catheter. Typically 1-2ml is required.
Lidocaine with 1:200,000 epinephrine solutionDrug
Also called Lignocaine with 1:200,000 adrenaline solution
100ml of 1% lidocaine with 1:200,000 epinephrine is diluted into 900ml of 0.9% Sodium Chloride to make the tumescent anaesthetic solution, which is required when using endovenous laser ablation.
Sodium BicarbonateDrug
10ml of 8.4% Sodium Bicarbonate is added into the tumescent anaesthetic solution, to buffer the pH to 7.4. Tumescent anaesthetic solution is required when using endovenous laser ablation.
Sodium Tetradecyl SulphateDrug
Also called Fibrovein Solution for Injection
1.5% of Sodium Tetradecyl Sulphate, marketed as Fibrovein, will be used with the mechanochemical ablation device (ClariVein®). This is a sclerosing agent with Manufacturer Authorisation, and it will be used unmodified. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein.
| Study group | Role | What they receive |
|---|---|---|
| EndoVenous Laser Ablation | Active comparator | EndoVenous Laser Ablation (EVLA) involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion. Receives: Device: EVLA; Drug: Lidocaine with 1:200,000 epinephrine solution; Drug: Sodium Bicarbonate |
| MechanoChemical Ablation (ClariVein®) | Active comparator | Mechanochemical ablation (MOCA) is performed by a device called ClariVein® which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. Receives: Device: ClariVein®; Drug: Lidocaine with 1:200,000 epinephrine solution; Drug: Sodium Tetradecyl Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural Pain
Patient is asked immediately after the procedure of their level of pain experienced during the intervention; measured on a standardised visual analogue scale (VAS).
Measured: Up to end of intervention
Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment.
Measured: At 1 year
Secondary outcomes (15)
Aberdeen Varicose Vein Questionnaire (AVVQ)
Disease Specific quality of life
Measured: 1 week, 6 weeks, 6 months, 1 year
Chronic Venous disease quality of life Questionnaire (CIVIQ-20)
Disease Specific quality of life
Measured: 1 week, 6 weeks, 6 months, 1 year
VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym)
Disease Specific quality of life
Measured: 1 week, 6 weeks, 6 months, 1 year
Short Form 36
Generic quality of life
Measured: 1 week, 6 weeks, 6 months, 1 year
EuroQol (EQ5D)
Generic quality of life
Measured: 1 week, 6 weeks, 6 months, 1 year
Post-procedural Pain
One week pain diary
Measured: Throughout the first week after the procedure
Analgesia Use
One week analgesia diary
Measured: 1 week
Bruising visual analogue scale
Appreciation of the severity of bruising
Measured: 1 week, 6 weeks, 6 months, 1 year
Satisfactory visual analogue scale
Satisfaction with treatment
Measured: 1 week, 6 weeks, 6 months, 1 year
Cosmesis visual analogue scale
Satisfaction with cosmetic result from treatment
Measured: 1 week, 6 weeks, 6 months, 1 year
Recovery time
Time taken to return to work (if employed) and daily activity
Measured: 1 week, 6 weeks, 6 months, 1 year
Complications
Any numbness, persistent bruising, tenderness, skin loss/ulceration, lumpiness, development of thread, skin staining, wound infection, deep vein thrombosis, pulmonary embolus, stroke, loss of vision, damage to major artery, vein or nerve.
Measured: 1 week, 6 weeks, 6 months, 1 year
Recurrence of Varicose Veins
Combination of history taking, clinical examination and duplex ultrasound assessment.
Measured: 1 week, 6 weeks, 6 months, 1 year
Disease Progression
Comparison of clinical and duplex ultrasound findings between follow-ups.
Measured: 1 week, 6 weeks, 6 months, 1 year
Need for Further Treatment
Comparison of clinical and duplex ultrasound findings between follow-ups is made and should there be failure of intervention or recurrence of varicose veins, there would be consultation between surgeon and patient to decide whether further intervention is required.
Measured: 1 week, 6 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Aug 2018
- Study completion4 Sep 2023
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ian Chetter, MBChB,MD,FRCS, Principal investigator, Hull University Teaching Hospitals NHS TrustAbduraheem Mohamed, MBBS,BSc,MRCS, Principal investigator, Hull University Teaching Hospitals NHS TrustDaniel Carradice, MBBS,MRCS,DipHE, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627846
- Sponsor's protocol ID
- R1788
- Acronym
- LAMA
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2015
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mohamed AH, Leung C, Wallace T, Smith G, Carradice D, Chetter I. A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial). Ann Surg. 2021 Jun 1;273(6):e188-e195. doi: 10.1097/SLA.0000000000003749.
PubMed 31977509Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation with ClariVein((R)) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials. 2016 Aug 24;17(1):421. doi: 10.1186/s13063-016-1548-1.
PubMed 27552990
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02627846
- Acronym / sponsor ID
- LAMA / R1788
- Conditions
- Varicose Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 11 Dec 2015 (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.
A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.
Detailed description
Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat.
Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat such as endovenous laser ablation (EVLA) should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort.
Since NICE guidelines, a new treatment technique known as mechanochemical ablation (MOCA) using ClariVein® has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment technique aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same.
This trial will randomly allocate volunteer patients to have their varicose veins treated with either EVLA or MOCA. The investigators will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results. Long term follow-ups will occur at 5 and 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoVenous Laser Ablation | Active comparator | Device: EVLA, Drug: Lidocaine with 1:200,000 epinephrine solution, Drug: Sodium BicarbonateEndoVenous Laser Ablation (EVLA) involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion. |
| MechanoChemical Ablation (ClariVein®) | Active comparator | Device: ClariVein®, Drug: Lidocaine with 1:200,000 epinephrine solution, Drug: Sodium Tetradecyl SulphateMechanochemical ablation (MOCA) is performed by a device called ClariVein® which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or over
- Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
- Clinical grades C2-C6 on the CEAP system
- Superficial axial incompetence with proposed treatment lengths of at least 10cm
- Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
Key exclusion criteria (12 listed)
- One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
- Unwilling or inability to comply with the requirements for follow-up visits
- Known allergy to medications or dressings used in the treatment
- Known right to left circulatory shunt
- Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
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 |
|---|---|---|
| EVLAAlso: Endovenous Laser Ablation1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. The EVLA fibre is introduced into the vein using the Seldinger technique and its tip will be positioned under duplex ultrasound (DUS). Then tumescent anaesthetic, made of a solution of 100ml of 1% Lidocaine with 1:200,000 epinephrine in 900ml of 0.9% Sodium Chloride and buffered to pH 7.4 with 10ml of 8.4% Sodium Bicarbonate, will be infiltrated around the target axial vein under DUS using a spinal needle and a peristaltic pump. Following deployment of appropriate laser safety precautions, the laser energy will be delivered via the fibre. The wavelength used is 1470nm, with NeverTouch Gold-Tip fibre, at 10W power. This laser light energy is converted into heat inducing a permanent, non-thrombotic occlusion. | Device | EndoVenous Laser Ablation |
| ClariVein®Also: Mechanochemical Ablation1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. MOCA is performed by a device called ClariVein® (Vascular Insights, UK) which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. The sclerosant will be Sodium Tetradecyl Sulphate (STS), marketed as Fibrovein. Concentration of 1.5% Fibrovein will be used, and maximum of 12ml. | Device | MechanoChemical Ablation (ClariVein®) |
| Lidocaine with 1:200,000 epinephrine solutionAlso: Lignocaine with 1:200,000 adrenaline solutionIt is used as local anaesthetic given via subcutaneous injection, so that the skin is numb prior to the introduction of either endovenous laser ablation or mechenochemical ablation catheter. Typically 1-2ml is required. | Drug | EndoVenous Laser Ablation, MechanoChemical Ablation (ClariVein®) |
| Lidocaine with 1:200,000 epinephrine solutionAlso: Lignocaine with 1:200,000 adrenaline solution100ml of 1% lidocaine with 1:200,000 epinephrine is diluted into 900ml of 0.9% Sodium Chloride to make the tumescent anaesthetic solution, which is required when using endovenous laser ablation. | Drug | EndoVenous Laser Ablation |
| Sodium Bicarbonate10ml of 8.4% Sodium Bicarbonate is added into the tumescent anaesthetic solution, to buffer the pH to 7.4. Tumescent anaesthetic solution is required when using endovenous laser ablation. | Drug | EndoVenous Laser Ablation |
| Sodium Tetradecyl SulphateAlso: Fibrovein Solution for Injection1.5% of Sodium Tetradecyl Sulphate, marketed as Fibrovein, will be used with the mechanochemical ablation device (ClariVein®). This is a sclerosing agent with Manufacturer Authorisation, and it will be used unmodified. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. | Drug | MechanoChemical Ablation (ClariVein®) |
Primary outcome
Intra-procedural Pain
Time frame: Up to end of intervention
Patient is asked immediately after the procedure of their level of pain experienced during the intervention; measured on a standardised visual analogue scale (VAS).
Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment.
Time frame: At 1 year
15 secondary outcomes
Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: 1 week, 6 weeks, 6 months, 1 year
Chronic Venous disease quality of life Questionnaire (CIVIQ-20)
Time frame: 1 week, 6 weeks, 6 months, 1 year
VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym)
Time frame: 1 week, 6 weeks, 6 months, 1 year
Short Form 36
Time frame: 1 week, 6 weeks, 6 months, 1 year
EuroQol (EQ5D)
Time frame: 1 week, 6 weeks, 6 months, 1 year
Post-procedural Pain
Time frame: Throughout the first week after the procedure
Analgesia Use
Time frame: 1 week
Bruising visual analogue scale
Time frame: 1 week, 6 weeks, 6 months, 1 year
Satisfactory visual analogue scale
Time frame: 1 week, 6 weeks, 6 months, 1 year
Cosmesis visual analogue scale
Time frame: 1 week, 6 weeks, 6 months, 1 year
Recovery time
Time frame: 1 week, 6 weeks, 6 months, 1 year
Complications
Time frame: 1 week, 6 weeks, 6 months, 1 year
Recurrence of Varicose Veins
Time frame: 1 week, 6 weeks, 6 months, 1 year
Disease Progression
Time frame: 1 week, 6 weeks, 6 months, 1 year
Need for Further Treatment
Time frame: 1 week, 6 weeks, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 31977509Mohamed AH, Leung C, Wallace T, Smith G, Carradice D, Chetter I. A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial). Ann Surg. 2021 Jun 1;273(6):e188-e195. doi: 10.1097/SLA.0000000000003749.
- Derived from this study: PubMed 27552990Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation with ClariVein((R)) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials. 2016 Aug 24;17(1):421. doi: 10.1186/s13063-016-1548-1.
- Abstract LinkLink provided by the sponsor.
- Abstract LinkLink provided by the sponsor.
- Abstract LinkLink 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.
Ian Chetter, MBChB,MD,FRCS principal investigator
Hull University Teaching Hospitals NHS Trust
Abduraheem Mohamed, MBBS,BSc,MRCS principal investigator
Hull University Teaching Hospitals NHS Trust
Daniel Carradice, MBBS,MRCS,DipHE principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EVLA, ClariVein® and Lidocaine with 1:200,000 epinephrine solution in people with Varicose Veins, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural Pain (time frame: Up to end of intervention). 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 NCT02627846, 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 21 Sep 2023.