Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.

June 1, 2026 updated by: Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trauma effects
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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?
Time Frame: 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?
Time Frame: 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)
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

Investigators

  • Principal Investigator: Atıf Akçevin, Prof. Dr., Koc University Hospital
  • Study Director: Ozan Onur Balkanay, Prof. Dr., İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIP-33003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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