Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.
Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data obtained from equivalent devices, and CE certificates were issued for devices exhibiting similar characteristics. Following the transition to the MDR, the European Commission's Guidance Document MEDDEV 2.12/2 highlighted that Notified Bodies, which issued CE certificates under the previous regime, must now organize Post-Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously marked with the CE mark under the old regulations are used safely for patients throughout their lifecycle.
Primary Objective To demonstrate the performance of the Bıçakcılar Vent Catheter in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, passage manipulation, insertion and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its form
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary Endpoints The primary endpoints have been designed to encompass all clinical outcomes that characterize the device's performance. The evaluation items listed below, which are directly related to the Bıçakcılar Vent Catheter, will be measured using a Likert scale with values ranging from 1 to 5.
- Presence of bleeding
- Impact of trauma
- Manipulation during insertion
- Placement
- Removal (including removal of the stylet, if applicable)
- Conformity to intended use/Drainage capability
- Blockage formation in the ports
- Presence of residue
- Effective use
- Retention of shape
Secondary Endpoints Since factors such as the surgeon performing the operation, the perfusionist operating the heart-lung machine, and the patients' clinical characteristics may act as confounding variables, other variables affecting the primary endpoints will be identified through secondary endpoints.
- General and demographic information
- Concomitant diseases
- Concomitant treatments
- Biochemical findings
- Echocardiographic findings
- Total duration of the procedure
- Type of procedure
- Vital and cardiac assessments
- Evaluations related to the Vent catheter
- Perfusion evaluations
- Cardioplegia evaluations
- Data on adverse events and complications
Definition of Participants (Volunteers) / Study Population Patients for whom a decision has been made by their physician to undergo routine surgical procedures using cardiopulmonary bypass, and for whom the use of a vent catheter is planned during the procedure
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gizem Özdemir, Biomedical Engineer
- Número de teléfono: +90 5346137760
- Correo electrónico: gizemozdemir@kocyasa.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
- Patients with diseased or abnormal tissue at the catheter insertion site
- Patients with intracardiac and/or major intravascular thrombi and/or masses
- Patients with left atrial/ventricular myxoma
- Patients who have difficulty understanding or complying with the study
- Patients who may present a conflict of interest (e.g., relatives of employees of the sponsoring company)
- Patients who have participated in any clinical trial within the past 30 days
Descripción
Inclusion Criteria:
Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,
- Patients for whom the use of a vent catheter is planned during surgery
- Patients who, in the "Use of Patient Data for Educational and Research Purposes" section of the Department of Cardiovascular Surgery Informed Consent Form, have given permission for their data to be used
Exclusion Criteria:
• Patients with diseased or abnormal tissue in the catheter placement site
- Patients with intracardiac and/or major intravascular thrombi and/or masses
- Patients with left atrial/ventricular myxoma
- Patients who have difficulty understanding or complying with the study
- Patients who may pose a conflict of interest (e.g., relatives of employees of the sponsoring company)
- Patients who have participated in any clinical trial within the past 30 days
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Trauma effects
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
Primary endpoints are structured to encompass all clinical use outcomes characterizing device performance.
Evaluation items directly related to the Bıçakcılar Vent Catheter will be measured using a Likert scale with values ranging from 1 to 5.
|
It will be measured during the surgery up to 6 hours.
|
|
Presence of bleeding
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used the 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Manipulation during insertion
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Catheter placement
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used the 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Catheter removal
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used the 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Removal of the stylet (If the catheter contains a stylet)
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used the 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Suitability of the device for its intended use / emptying capability
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Blockage in the holes during emptying
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Was there any residue left on the catheter surface after the removal procedure was completed?
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Was its use as a filler for air extraction effective?
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
|
Has the device retained its pre-operation form? (Evaluate for deformation, bending, or fractures)
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Atıf Akçevin, Prof. Dr., Koc University Hospital
- Director de estudio: Ozan Onur Balkanay, Prof. Dr., İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CIP-33003
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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