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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Gizem Özdemir, Biomedical Engineer
- Numero di telefono: +90 5346137760
- Email: gizemozdemir@kocyasa.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
- 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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Trauma effects
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Atıf Akçevin, Prof. Dr., Koc University Hospital
- Direttore dello studio: Ozan Onur Balkanay, Prof. Dr., İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CIP-33003
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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