Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.
Starting soon
Conditions studied: Cardiopulmonary Bypass Surgery
In brief
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
Key facts
- Study ID
- NCT07628920
- Run by
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
- People needed
- 45
- Starts
- 2026-07-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- • 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
Full record on ClinicalTrials.gov
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