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    Summary
    EudraCT Number:2022-003499-18
    Sponsor's Protocol Code Number:PI2022_843_0111
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-12
    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 number2022-003499-18
    A.3Full title of the trial
    Is there a concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology to determine the microscopic inflammation at the ileal resection margins in Crohn’s ileal disease?
    Le Cellvizio avec injection de fluorescéine est-il concordant à l’anatomopathologie pour déterminer le caractère inflammatoire ou non de la zone de section iléale dans la maladie de Crohn iléale ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is there a concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology to determine the microscopic inflammation at the ileal resection margins in Crohn’s ileal disease?
    Le Cellvizio avec injection de fluorescéine est-il concordant à l’anatomopathologie pour déterminer le caractère inflammatoire ou non de la zone de section iléale dans la maladie de Crohn iléale ?
    A.3.2Name or abbreviated title of the trial where available
    CELLVICROHN
    CELLVICROHN
    A.4.1Sponsor's protocol code numberPI2022_843_0111
    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 SponsorCHU Amiens-Picardie
    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 supportCHU Amiens-Picardie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressCHU Amiens-Picardie
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.6E-mailmattoug.salah@chu-amiens.fr
    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 FLUOCYNE 10%
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    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 nameFLUOCYNE 10%, solution for injection I.V.mg/mL
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    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 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
    Crohn’s ileal disease
    maladie de Crohn iléale
    E.1.1.1Medical condition in easily understood language
    Crohn’s ileal disease
    maladie de Crohn iléale
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.
    est d’évaluer l’intérêt du Cellvizio avec injection par voie intra-veineuse de fluorescéine en peropératoire pour déterminer le site de section muqueuse grêlique pour les maladies de Crohn iléales terminales (concordance avec l’anatomopathologie).
    E.2.2Secondary objectives of the trial
    Evaluate the interest of Cellvizio with the intravenous injection of fluorescein intraoperatively (concordance with the anatomopathology):
    - for the study of the ileal serosa for (search for transmural Crohn's disease)
    - to assess whether or not the resected mesentery is inflammatory
    Assess the additional bowel length that would need to be resected to be microscopically healthy at the margin.
    To constitute a video collection of the different healthy and pathological aspects of the hail (mucosa, serosa) but also of the mesentery
    Évaluer l’intérêt du Cellvizio avec l'injection par voie intra-veineuse de fluorescéine en peropératoire (concordance avec l’anatomopathologie) :
    - pour l’étude de la séreuse iléale pour (recherche d’une atteinte crohnienne transmurale)
    - pour évaluer le caractère inflammatoire ou non du mésentère réséqué
    Évaluer la longueur de grêle supplémentaire qu’il faudrait réséquer pour être en marge microscopiquement saine.
    De constituer une collection vidéo des différents aspects sains et pathologiques du grêle (muqueuse, séreuse) mais aussi du mésentère
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patient ≥ 18 years old
    Patient with end-stage ileal Crohn's disease (regardless of phenotype) requiring ileocaecal resection
    Patient majeur ≥ 18 ans
    Patient ayant une maladie de Crohn iléale terminale (quel que soit le phénotype) nécessitant une résection iléocæcale
    E.4Principal exclusion criteria
    - Patients with Crohn's disease operated on urgently for peritonitis
    - Patient with a contraindication to the injection of fluorescein (allergy to fluorescein, severe allergy to a drug, moderate to severe renal insufficiency, hepatic insufficiency, history of cardiopulmonary disease, diabetes, concomitant treatments (in particular beta-blockers , including beta-blockers in eye drops)).
    - Patients ayant une maladie de Crohn opérée en urgence pour péritonite
    - Patient ayant une contre-indication à l’injection de fluorescéine (allergie à la fluorescéine, allergie sévère à un médicament, insuffisance rénale modérée à sévère, Insuffisance hépatique, antécédents de maladie cardio-pulmonaire, diabète, traitements concomitants (notamment bêta-bloquants, y compris les bêtabloquants en collyre)).
    E.5 End points
    E.5.1Primary end point(s)
    is the microscopically healthy or inflammatory character of the ileal mucosal section margin for Cellvizio and pathology.
    est le caractère microscopiquement sain ou inflammatoire de la marge de section muqueuse iléale pour le Cellvizio et l’anatomopathologie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The day of surgery
    Le jour de l'intervention chirurgicale
    E.5.2Secondary end point(s)
    The concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology for the inflammation of the serosa (transmural inflammation) and of the mesentery and the length of ileum (in cm) between the surgical margin and the theorical resection site to be in a non-inflammatory area at the Cellvizio (on the mucosa and on the serosa)..
    Caractère microscopiquement sain ou inflammatoire de la séreuse (atteinte transmurale) pour le Cellvizio et pour l’anatomopathologie
    Caractère microscopiquement sain ou inflammatoire du mésentère pour le Cellvizio et l’anatomopathologie
    La longueur de grêle comprise entre la marge de section chirurgicale iléale et la marge théorique au cellvizio (sur le versant muqueux et sur la séreuse et sur le mésentère) en cm
    E.5.2.1Timepoint(s) of evaluation of this end point
    The day of surgery
    Le jour de l'intervention chirurgicale
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States No
    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 last visit of the last subject undergoing the trial ●
    La dernière visite du dernier patient inclus
    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 months24
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state41
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 41
    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)
    None
    Néant
    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 Decision2023-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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