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    Summary
    EudraCT Number:2015-005535-40
    Sponsor's Protocol Code Number:3599-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-05
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-005535-40
    A.3Full title of the trial
    A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated (FS VH S/D 500 s-apr) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery
    Estudio aleatorizado, controlado, para evaluar la eficacia y seguridad del adhesivo tisular de fibrina, sometido a los procesos de calentamiento por vapor y de solvente/detergente (FS VH S/D 500 s-apr), en comparación con el sellador dural DuraSeal como adyuvante en la reparación con suturas de la duramadre en cirugía cranial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not applicable
    No aplica
    A.4.1Sponsor's protocol code number3599-001
    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 SponsorBaxter Healthcare Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBaxter Healthcare Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Healthcare Corporation
    B.5.2Functional name of contact pointAriane Liebchen
    B.5.3 Address:
    B.5.3.1Street AddressHolger-Crafoord-Straße 26
    B.5.3.2Town/ cityHechingen
    B.5.3.3Post code72379
    B.5.3.4CountryGermany
    B.5.4Telephone number+3493464 46 47
    B.5.5Fax number+497471175050
    B.5.6E-mailariane_liebchen@baxter.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 TISSEEL
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER DEUTSCHLAND GMBH (DE); BAXTER CZECH SPOL. S R.O. (CZ); BAXTER, S.L. (ES)
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.2Product code FS VH S/D 500 s-apr
    D.3.4Pharmaceutical form Solution for sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN FIBRINOGEN
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number91
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN THROMBIN
    D.3.9.1CAS number 9002-04-4
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIUM CHLORIDE
    D.3.9.1CAS number 10035-04-8
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µmole/ml micromole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPROTININ
    D.3.9.1CAS number 9087-70-1
    D.3.9.3Other descriptive nameAPROTININ (synthetic)
    D.3.9.4EV Substance CodeSUB05546MIG
    D.3.10 Strength
    D.3.10.1Concentration unit KIU/ml kallikrein inactivator unit/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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) Yes
    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 Yes
    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
    Intra-operative CSF leak
    Pérdida intraoperatoria de líquido cefalorraquídeo
    E.1.1.1Medical condition in easily understood language
    Leak of cerebrospinal fluid during surgery
    Pérdida de líquido cefalorraquídeo durante la cirugía
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10024091
    E.1.2Term Leakage of cerebrospinal fluid
    E.1.2System Organ Class 100000004852
    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 efficacy of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure.
    Evaluar la eficacia de FS VH S/D 500 s-apr en comparación con el sellador dural DuraSeal como complemento al cierre de la duramadre suturada.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure.
    Evaluar la seguridad de FS VH S/D 500 s-apr en comparación con el sellador dural DuraSeal como complemento al cierre de la duramadre suturada.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients >=18 years of age undergoing craniotomy/craniectomy for pathological processes in the PF or ST region
    2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed
    3. Patients must be willing to receive peri-operative antibiotic prophylaxis
    4. Female patients of childbearing potential must present with a negative serum pregnancy test, and must agree to employ adequate birth control measures [restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products] for the duration of their participation in the study
    5. Patients are willing and able to comply with the requirements of the protocol
    INTRA-OPERATIVE
    1. Patients with surgical wound classification Class I
    2. The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the IP
    3. Patient’s CSF leak was present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue); either spontaneously or upon Valsalva manoeuver (25 cm H2O for up to 5 - 10 seconds)
    1. Pacientes que tengan >= 18 años cumplidos y que vayan a someterse a una craneotomía o cranectomía por procesos patológicos en la región de la FP o ST
    2. Los pacientes deben estar dispuestos y tener capacidad para participar en el estudio y prestarán CI por escrito antes de realizar cualquier valoración específica del protocolo
    3. Los pacientes deben estar dispuestos a recibir profilaxis antibiótica perioperatoria
    4. Si son mujeres en edad fértil, las pacientes presentarán un test de embarazo negativo en sangre y aceptarán utilizar medidas anticonceptivas adecuadas [que se reducen a la abstinencia sexual, uso de métodos anticonceptivos de barrera, dispositivos intrauterinos o anticonceptivos hormonales sujetos a licencia] durante toda su participación en el estudio
    5. Los pacientes estarán dispuestos y tendrán capacidad para cumplir los requisitos del protocolo
    INTRAOPERATORIOS
    1. Pacientes con herida quirúrgica clasificada como Clase I
    2. El manguito dural original a lo largo del margen de la craneotomía a cada lado es adecuado, según el criterio del cirujano, para facilitar la sutura y para permitir el área de superficie suficiente para la adherencia del PEI.
    3. La fístula de líquido cefalorraquídeo del paciente estaba presente dentro de la cirugía tras la finalización del cierre dural primario (con o sin duroplastia no autóloga o tejido autólogo); ya sea de forma espontánea o tras la maniobra de Valsalva (25 cm H2O durante un máximo de 5 - 10 segundos).
    E.4Principal exclusion criteria
    1. Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
    2. Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery
    3. Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
    4. Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
    5. Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for >=8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)
    6. Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol [PEG], trilysine amine)
    7. Patients with a known hypersensitivity to US Federal Drug & Cosmetic Blue #1 dye
    8. Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature >100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of <20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters
    9. Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
    10. Female patients who are nursing
    11. Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrolment or anticipated in the 60-day Follow-up period
    12. Patients with severely altered renal function as confirmed by local laboratory reference ranges for serum creatinine and/or hepatic function (alanine aminotransferase [ALT], aspartate aminotransferase >3 × upper limit of normal [ULN])
    13. Patients who currently have or have had a compromised immune system (such as Acquired Immune Deficiency Syndrome [AIDS]) or autoimmune disease, or were on chronic immunosuppressant agents
    14. Patients with uncontrolled diabetes as evidenced by the institution’s standard of care (glycated haemoglobin [HbA1c] >7%, blood glucose, etc.)
    15. Patients with traumatic injuries to the head
    16. Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff
    17. Patients requiring surgical approaches that would not allow sutured dural closure such as trans-sphenoidal or translabyrinthine/-petrosal/-mastoid. Superficial penetration of mastoid air cells is allowed
    18. Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure
    19. Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura
    20. Patients with confined bony structures where nerves are present and neural compression may result due to swelling
    INTRA-OPERATIVE
    1. Patient has a gap between durotomy edges of >2 mm after primary dural closure in the judgment of the investigator
    2. Patients requiring the use of implants made of synthetic materials coming into direct contact with dura
    3. Patient has 2 or more separate dural defects
    4. Patients with intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection
    5. Placement of Gliadel Wafers
    6. Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure
    7. Patients in whom application of the Valsalva manoeuver is not found appropriate due to increased safety risk
    8. Patients requiring the use of other FSs or PEG-based sealants
    9. Patients with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure
    1. Pacientes con lesión de la duramadre producida en una intervención quirúrgica reciente que pueda producir pérdida de LCR
    2. Pacientes que se hayan sometido a quimioterapia, excepto el tratamiento hormonal, durante las 3 semanas anteriores a la intervención programada, o con quimioterapia programada en los 7 días posteriores a la intervención
    3. Pacientes con radioterapia en la zona quirúrgica o radioterapia de fraccionamiento convencional programada en los 7 días posteriores a la intervención
    4. Pacientes con una craneotomía o cranectomía previa en los 6 meses previos a la cirugía del estudio
    5. Tratamiento de larga duración con corticosterioides (que se establece como el uso diario de corticosteroides durante >=8 semanas) con fines distintos de la disminución de los síntomas de la quimioterapia sistémica (excepto si dichos esteroides fueron interrumpidos 4 semanas antes de la cirugía programada)
    6. Pacientes con hipersensibilidad conocida a los componentes del PI o del control (fibrinógeno humano, aprotinina sintética, albúmina humana, FXIII humano, citrato trisódico, histidina, niacinamida, polisorbato 80, trombina humana, PEG, trilisina-amina)
    7. Pacientes con hipersensibilidad conocida a la tinción azul n.º 1 de la US Federal Drug & Cosmetic (Ley Federal de Medicamentos y Cosméticos de los Estados Unidos)
    8. Signos de infección manifestados por un elemento cualquiera de los siguientes: exploración clínica que confirme el diagnóstico de infección, fiebre (temperatura >100,7°F o 38,2°C), urocultivo positivo, hemocultivo positivo, radiografía de tórax positiva, infección en toda la ruta quirúrgica prevista. Se permite una cifra de leucocitos de < 20000 si el paciente está siendo tratado con esteroides a falta de todos los demás parámetros de la infección
    9. En caso de ser mujeres en edad fértil, las pacientes con un test de embarazo positivo o con intención de quedarse embarazadas durante el período del ensayo clínico
    10. En caso de ser mujeres, las pacientes en período de lactancia
    11. Los pacientes expuestos a otro fármaco o dispositivo en investigación en un ensayo clínico durante los 30 días previos a la inclusión o que tengan prevista dicha exposición en el período de seguimiento de 60 días
    12. Pacientes con la función renal gravemente alterada según confirmación de los intervalos de referencia del laboratorio local con respecto a la creatinina sérica o a la función hepática (ALT, aspartato-aminotransferasa >3 × LSN) o ambas.
    13. Pacientes que actualmente sufran o que hayan sufrido una enfermedad que comprometa de manera notable el sistema inmunitario (como SIDA, enfermedad autoinmune o tratamiento a largo plazo con inmunosupresores)
    14. Pacientes que incumplan el tratamiento o con tratamiento insuficiente para la diabetes a juicio del tratamiento de referencia de la institución (hemoglobina glucosilada [HbA1c] >7%, glucosa en sangre, etc.)
    15. Pacientes con traumatismos craneales
    16. Pacientes con lesión de la duramadre durante una craneotomía o una cranectomía que no se puede eliminar mediante ampliación de la craneotomía o la cranectomía para recrear el manguito dural orginal
    17. Pacientes que requieran abordajes quirúrgicos que no permitirían un cierre de la duramadre mediante sutura, como por ejemplo, el abordaje transesfenoidal o los abordajes translaberíntico, transpetroso o transmastoideo. Se permite la penetración superficial de celdillas neumáticas mastoideas
    18. Pacientes con hidrocefalia, excepto la hidrocefalia oclusiva causada por una patología de la FP o de las rutas parciamente abiertas de líquido cefalorraquídeo, a tratar durante la intervención quirúrgica
    19. Drenajes de LCR existentes, cánula de Cushing o Dandy o agujeros de trépano que dañan la duramadre
    20. Pacientes con estructuras óseas limitadas en las que hay presencia de nervios y en los que la compresión neural puede resultar debida a una inflamación
    INTRAOPERATORIOS:
    1.Paciente que, a juicio del investigador, tiene un espacio > 2 mm entre los márgenes de la durotomía después del cierre primario de la duramadre.
    2. Pacientes que requieren el uso de implantes hechos de materiales sintéticos que entren en contacto directo con la duramadre
    3. Paciente con 2 o más defectos independientes de la duramadre
    4. Pacientes cicatrices de intersección en la ruta quirúrgica de la durotomía procedentes de una intervención previa que no pudieron ser eliminadas por completo por la resección programada de la duramadre
    5. Colocación de Implantes Gliadel
    6. Complicaciones graves intraoperatorias que requieren reanimación o desviación de la intervención quirúrgica prevista
    7. Pacientes a los que la aplicación de la maniobra de Valsalva no resulta adecuada debido al aumento del riesgo de seguridad
    8. Si se requiere el uso de otros selladores con base de FSS o PEG
    9. Pacientes con cualquier otro hallazgo intraoperatorio que, a juicio del cirujano, pueda impedir el desarrollo de los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who have neither of the following:
    - Intra-operative CSF leakage from dural repair after up to two FS VH S/D 500 s apr/control applications during Valsalva manoeuvre (25 cm H2O for up to 5 - 10 seconds)
    - Post-operative CSF leakage within 30 (+3) days post-operatively
    La proporción de pacientes en los que no se observa ninguno de los siguientes aspectos:
    - Pérdida intraoperatoria de LCR a través de la línea de sutura de la duramadre después de hasta dos aplicaciones de FS VH S/D 500 s apr o control durante la maniobra de Valsalva (25 cm H2O durante hasa 5 - 10 segundos)
    - Pérdida posoperatoria de LCR durante los 30 (+3) días posoperatorios
    E.5.1.1Timepoint(s) of evaluation of this end point
    intraoperative : 3 Minutes
    post-operative : Day 30 (+-3)
    Intraoperatoria: 3 minutos
    Posoperatoria: 30 días (+-3)
    E.5.2Secondary end point(s)
    Efficacy:
    - Incidence of intra-operative CSF leakage following final Valsalva manoeuvre
    - Incidence of CSF leaks within 30 (+3) days post-operatively
    - Time in surgery (minutes)
    - Time from dural closure (application of investigational product) until end of surgery
    - Length of stay in hospital (days)

    Safety:
    - Incidence of CSF leaks within 60 (+3) days post-operatively
    - Incidence of adverse events (AEs) up to 60 (+3) days post-operatively
    - Incidence of surgical site infections (SSIs) according to the United States (US) National Healthcare Safety Network (NHSN) within 30 (+3) days post-operatively
    - Number of unplanned interventions within 30 (+3) days post-operatively
    - Abnormal laboratory values and vital signs (e.g., elevated white blood cell [WBC] count, fever [temperature >100.7°F or 38.2°C], tachycardia [pulse >100], hypotension [mean arterial pressure <60])
    Evaluaciones de eficacia:
    - Incidencia de la pérdida intraoperatoria de LCR tras la maniobra de Valsalva final
    - Incidencia de derrames de LCR durante los 30 (+3) días posoperatorios
    - Tiempo de la cirugía (minutos)
    - Tiempo desde la sutura de la duramadre (aplicación del producto en investigación) hasta la finalización de la cirugía
    - Duración de la estancia en el hospital (días)
    Evaluaciones de seguridad:
    - Incidencia de derrames de LCR durante los 60 (+3) días posoperatorios
    - Incidencia de acontecimientos adversos (AA) a los 60 (+3) días del posoperatorio
    - Incidencia de infecciones en el sitio quirúrgico (ISQ) según la National Healthcare Safety Network (Red de Seguridad del Sistema de Atención Sanitaria Nacional) (NHSN) a los 30 (+3) días del posoperatorio
    - Número de intervenciones no programadas desde el día de la cirugía hasta 30 días (± 3) después de la intervención
    - Valores de laboratorio y constantes vitales alterados (por ej., elevación de la cifra de leucocitos [LEU, GB], fiebre [temperatura >100,7°F o 38,2°C], taquicardia [pulso >100], hipotensión [tensión arterial media <60])
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 0 (day of surgery), day 5 (+-2) , day 30 (+-3), day 60 (+-3)
    día 0 (día de la cirugía), día 5 (+-2) , día 30 (+-3), día 60 (+-3)
    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 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 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 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 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
    DuraSeal sistema de sellado dural para la cirugía craneal, con marcado CE de producto sanitario
    Integra DuraSeal Dural Sealant System for Cranial Surgery, CE marked Medical Device
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Germany
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 last subject (LVLS)
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 309
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 167
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 286
    F.4.2.2In the whole clinical trial 476
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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