Cardiopulmonary BypassNCT07620847
Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass
An observational study of Cardiopulmonary Bypass, run by Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş..
Trial summary
Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- coronary artery perfusion cannula
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device using data obtained from all cases collected within a timeframe that is clinically appropriate and sufficient. In this context, a minimum sample size is being established without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be constructed by including participants such that, in a 4-option design with two types of operations and two types of cannulas, there will be at least 5 cases even for the option with the fewest patients operated on in consecutive operations.
Who may be able to join
- 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 coronary artery perfusion cannula is planned during surgery
- Patients who, prior to surgery, have provided consent in the "Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes" section regarding the use of their data
Who cannot join
- Patients with ostial calcification and/or an ostium that is too small for the cannula tip to fit through,
- Patients known to have hypersensitivity to any of the materials used in the device components
- Patients who have difficulty understanding the study and complying with it
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer contact
About this study
Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- coronary artery perfusion cannula
- Keywords
- Coronary artery perfusion, coronary ostium, cardioplegia, cardioplegia cannula, antegrade cannula, antegrade cardioplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery perfusion cannulaDevice
The Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of bleeding
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.
Measured: It will be measured during the operation up to 6 hours.
Impact of trauma
It will be used a 5-likert scale.
Measured: During the operation
Manipulation during placement
It will be used a 5-likert scale.
Measured: During the operation
Cannula leakage
It will be used a 5-likert scale.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620847
- Sponsor's protocol ID
- CIP-33004a
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07620847
- Acronym / sponsor ID
- CIP-33004a
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Coronary artery perfusion, coronary ostium, cardioplegia, cardioplegia cannula, antegrade cannula, antegrade cardioplegia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.University, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device using data obtained from all cases collected within a timeframe that is clinically appropriate and sufficient. In this context, a minimum sample size is being established without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be constructed by including participants such that, in a 4-option design with two types of operations and two types of cannulas, there will be at least 5 cases even for the option with the fewest patients operated on in consecutive operations.
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- Patients with ostial calcification and/or an ostium that is too small for the cannula tip to fit through,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery perfusion cannulaThe Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery. | Device | – |
Primary outcome
Presence of bleeding
Time frame: It will be measured during the operation 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.
Impact of trauma
Time frame: During the operation
It will be used a 5-likert scale.
Manipulation during placement
Time frame: During the operation
It will be used a 5-likert scale.
Cannula leakage
Time frame: During the operation
It will be used a 5-likert scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass, run by Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer (+90 5346137760, gizemozdemir@kocyasa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of bleeding (time frame: It will be measured during the operation up to 6 hours.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.