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    Summary
    EudraCT Number:2021-006904-34
    Sponsor's Protocol Code Number:CHD21_0121
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-006904-34
    A.3Full title of the trial
    Evaluation of the interest of perianal infiltration during thermodestruction of haemorrhoidal disease by Radiofrequency (RAFAELO® procedure)
    Evaluation de l’intérêt de l’infiltration périanale au cours de la thermodestruction de la maladie hémorroïdaire par Radiofréquence (procédé RAFAELO®)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the interest of perianal infiltration during thermodestruction of haemorrhoidal disease by Radiofrequency (RAFAELO® procedure)
    Evaluation de l’intérêt de l’infiltration périanale au cours de la thermodestruction de la maladie hémorroïdaire par Radiofréquence (procédé RAFAELO®)
    A.3.2Name or abbreviated title of the trial where available
    RAFAELOCAL
    RAFAELOCAL
    A.4.1Sponsor's protocol code numberCHD21_0121
    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 SponsorCentre Hospitalier Départemental Vendée
    B.1.3.4CountryFrance
    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 supportCentre Hospitalier Départemental Vendée
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Départemental Vendée
    B.5.2Functional name of contact pointChloé MOREAU
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard Stéphane MOREAU
    B.5.3.2Town/ cityLA ROCHE SUR YON
    B.5.3.3Post code85925
    B.5.3.4CountryFrance
    B.5.6E-mailchloe.moreau@ght85.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Ropivacaïne
    D.2.1.1.2Name of the Marketing Authorisation holderASPEN PHARMA TRADING LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRopivacaïne
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemorrhoidal surgery by thermodestruction
    Chirurgie hémorroïdaire par thermodestruction
    E.1.1.1Medical condition in easily understood language
    Hemorrhoidal surgery by thermodestruction
    Chirurgie hémorroïdaire par thermodestruction
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Compare the pain experienced at H6 post-op.
    Comparer la douleur ressentie à H6 post-opératoire.
    E.2.2Secondary objectives of the trial
    Compare :
    1. The evolution of post-operative pain
    2. Complications within 30 days of surgery
    3. Time to return to work in active patients
    4. Post-operative analgesic and non-steroidal anti-inflammatory drug use
    5. Quality of life 1 month after haemorrhoidal surgery
    Comparer :
    1. L’évolution de la douleur post-opératoire
    2. Les complications survenues dans les 30 jours post-opératoires
    3. Le délai de reprise de l’activité professionnelle chez les patients en activité
    4. La consommation d’antalgiques et anti-inflammatoires non stéroïdiens (AINS) post-opératoires
    5. La qualité de vie 1 mois après la chirurgie hémorroïdaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient
    - Patient scheduled to undergo hemorrhoidal thermodestruction surgery (RAFAELO® procedure)
    - Patient able to understand the protocol and having given written informed consent to participate in the study
    - Patient affiliated to the social security system or entitled to it
    - Patient majeur
    - Patient devant avoir une chirurgie hémorroïdaire par thermodestruction (procédé RAFAELO®)
    - Patient en capacité de comprendre le protocole et ayant donné son consentement éclairé écrit pour participer à l'étude
    - Patient affilié au système de sécurité sociale ou ayant droit
    E.4Principal exclusion criteria
    - Patient < 18 years old
    - Patient with previous hemorrhoidectomy surgery (LONGO technique)
    - Patient with previous pexy ligation surgery (HAL-RAR technique)
    - Patients with known hypersensitivity to local anaesthetics or components
    - Patient with a long term (>1 month) analgesic treatment (level II and III)
    - Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
    - Patient who is pregnant, breastfeeding or able to procreate without contraception
    - Patient under guardianship, curatorship or deprived of liberty
    - Patient < 18 ans
    - Patient ayant déjà eu une chirurgie d’hémorroïdectomie (Technique de LONGO)
    - Patient ayant déjà eu une intervention par ligature pexie (Technique HAL-RAR)
    - Patient connu pour une hypersensibilité aux anesthésiques locaux ou composants
    - Patient ayant un traitement antalgique (palier II et III) au long cours (>1mois)
    - Patient participant à un autre protocole de recherche clinique interventionnel impliquant un médicament ou une investigation clinique portant sur un dispositif médical
    - Patiente enceinte, en cours d’allaitement ou en capacité de procréer sans moyen de contraception
    - Patient sous tutelle, curatelle ou privé de liberté
    E.5 End points
    E.5.1Primary end point(s)
    Visual Analogue Scale at H6 post-op (6 hours after the start of the operation).
    Echelle Visuelle Analogique (EVA) à H6 post-opératoire (6 heures après le début de l’intervention).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 hours after the start of the operation
    6 heures après le début de l’intervention
    E.5.2Secondary end point(s)
    1. VAS at H3, H12, H24 and M1 post-op
    2. Adverse events occurring within 30 days post-operatively. This will include the number of infections, AEs warranting re-hospitalization ....
    3. Date of return to work 4.
    4. classes of analgesics and NSAIDs taken in the 30 days post-operatively
    5. Preoperative and M1 postoperative HEMO-FISS-QoL
    1. EVA à H3, H12, H24 et M1 post-opératoire
    2. Evénements indésirables survenant dans les 30 jours post-opératoires. Seront notamment présentés le nombre d’infections, d’EvI justifiant une ré-hospitalisation ….
    3. Date de reprise de l’activité professionnelle
    4.Classes d’antalgiques et d’AINS consommés dans les 30 jours post-opératoires
    5. HEMO-FISS-QoL préopératoire et à M1 post-opératoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    H3, H12, H24 and M1 post-op
    H3, H12, H24 et M1 post-opératoire
    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 No
    E.6.4Safety No
    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 No
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Last visit of the last patient
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state134
    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)
    The management at the end of the research does not differ from the standard management.
    La prise en charge à la fin de la recherche ne diffère pas de la prise en charge standard.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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