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
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Gizem Özdemir, Biomedical Engineer
- 전화번호: +90 5346137760
- 이메일: gizemozdemir@kocyasa.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- 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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trauma effects
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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?
기간: 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?
기간: 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)
기간: 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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Atıf Akçevin, Prof. Dr., Koc University Hospital
- 연구 책임자: Ozan Onur Balkanay, Prof. Dr., İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CIP-33003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .