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    Summary
    EudraCT Number:2015-000730-30
    Sponsor's Protocol Code Number:R1788
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000730-30
    A.3Full title of the trial
    A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing the use of endovenous laser ablation and mechanochemical ablation in the management of varicose veins in the legs.
    A.3.2Name or abbreviated title of the trial where available
    Laser Ablation versus Mechanochemical Ablation (LAMA) trial
    A.4.1Sponsor's protocol code numberR1788
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHull and East Yorkshire Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull and East Yorkshire Hospitals NHS Trust
    B.5.2Functional name of contact pointDaniel Carradice
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Vascular Unit, Hull Royal Infirmary
    B.5.3.2Town/ cityAnlaby Road, Hull
    B.5.3.3Post codeHU3 2JZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482875875
    B.5.6E-maild.carradice1@googlemail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fibrovein 3% Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderSTD Pharmaceutical Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFibrovein 3% Solution for Injection
    D.3.2Product code UK/H/2775/001-4/DC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium tetradecyl sulphate
    D.3.9.1CAS number PL00398/0207
    D.3.9.3Other descriptive nameSTD injection
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fibrovein 1% Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderSTD Pharmaceutical Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFibrovein 1% Solution for Injection
    D.3.2Product code UK/H/2775/001-4/DC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium tetradecyl sulphate
    D.3.9.1CAS number PL00398/0206
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Varicose veins (VVs) or Superficial Venous Insufficiency (SVI) of the legs results from inflammation mediated damage to vein structure, allowing reverse flow. SVI affects 30% of adults and is associated with symptoms causing pain and disability; furthermore 3-10% have soft tissue damage and 1-2% suffer with venous ulcer disease.
    E.1.1.1Medical condition in easily understood language
    Valves within leg veins let blood through towards the body and heart. If they stop working properly, the leaking valves cause vein to become swollen and enlarged called "varicose veins".
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Randomised trials have established that closing veins using a heat source such as laser has significantly higher success rates than using chemicals, however heat treatment requires multiple additional uncomfortable injections of local anaesthetic. Recently a newer treatment mechanochemical ablation (MOCA) has been developed aiming to provide improved success rates similar to those seen with heat treatment, yet still avoid additional injections. This technology involves a spinning wire inside the vein which releases the chemical. The wire performs several actions which makes the vein more susceptible to the action of the chemical.

    Early non-randomised data suggests that MOCA may have similar success rates as heat, which seems very promising and this trial aims to randomly allocate patients to receive treatment with MOCA or with a popular heat method endovenous laser ablation (EVLA). The results can then be directly compared to see whether there are any differences in efficacy, ef
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 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
    E.4Principal exclusion criteria
    - 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 any medications used during treatment
    - Known right to left circulatory shunt
    - Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
    - Pelvic vein insufficiency
    - Active or recent thrombophlebitis (within 6 weeks)
    - Impalpable foot pulses with Ankle-Brachial Pressure Index of less than 0.8
    - Pregnancy or breast feeding
    - Active malignancy
    - Immobility
    - Have been included in other CTIMP trials within the last 6 months
    E.5 End points
    E.5.1Primary end point(s)
    The joint primary outcomes will assess the hypothesised advantaged and disadvantages of mechanochemical ablation (MOCA) when compared with endovenous laser ablation (EVLA), the current first choice treatment of superficial venous insufficiency (SVI).

    The first will be patient reported intra-procedural pain measured on a standardised visual analogue scale (VAS).

    The second will be technical efficacy at 1 year, with successful procedure defined as complete occlusion of the target vein segment. This will be assessed during duplex ultrasound. Recanalisation at 1 year is defined as blood flow within the target vein that had been treated. This is broken down into partial <25% or full ≥25% of the length of the treated vein.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will record their intra- and post-procedural pain on visual analogue scale (VAS). They will complete this immediately following axial treatment and again following tributary treatment. They will then go on to record this in a diary, providing a daily score for the first week.

    The type and daily dosage of any analgesia taken by patients will also be recorded in the diary for the first week by the patient.

    Patients will be followed up at 1 week, 6 weeks, 6 months and 1 year, during which they will be assessed with duplex ultrasound to determine the technical efficacy of the treatments.
    E.5.2Secondary end point(s)
    - Disease specific quality of life using the Aberdeen Varicose Vein Questionnaire (AVVQ), the Chronic Venous Insufficiency Questionnaire (CIVIQ), and the VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym).
    - Generic quality of life using the Short Form 36 (SF-36), EuroQol (EQ5D), and SF6D.
    - Bruising visual analogue scale on a 100mm unmarked scale.
    - Satisfaction visual analogue scale on a 100mm unmarked scale.
    - Cosmesis visual analogue scale on a 100mm unmarked scale.
    - Recovery time in terms of time taken to return to work and normal activities.
    - Clinical severity using the CEAP (Clinical severity, Etiology, Anatomy and Pathophysiology) classification, and Venous Clinical Severity Score (VCSS).
    - Complications
    - Surface planimetry of skin changes and complications estimated by measurement of tracing on acetate pre-printed with 1cm2 grids.
    - Duplex ultrasound to assess treatment efficacy.
    - Costs and resource use.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be followed up at 1 week, 6 weeks, 6 months and 1 year, during which they will be assessed for the secondary outcome measures.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Endovenous laser ablation (EVLA)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as the Last Visit of the Last Subject (LVLS) completing their 1 year follow-up assessment. Participants may be contacted and invited for further follow-up at 5 and 10 years, in order to assess the long-term effects of intervention, and these attendances are voluntary. Hospital records will be checked beforehand to establish the patient status and contact details.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Once the research has finished most participants will not require any ongoing treatment. Any who will benefit from additional interventional treatment will be provided with this prior to discharge. Some may require ongoing treatment in the form of compression hosiery and this will continue to be supplied by the NHS as in routine clinical care for patients outside of the trial.

    Patients developing....
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation n/a
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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