A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices

Официальное название

A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices

Обзор

The general objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality Level 3 (or better) data on the performance, safety and clinical benefits of Teleflex's vascular access devices when used in a real-world setting

Подробное описание

The primary objective is to provide high-quality Level 3 (or better), data as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully.

The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.

Вмешательства

• Устройство Central venous catheter
  Placement of a medical device to gain entry into the bloodstream, typically through a vein or artery, for the purpose of administering fluids, medications, blood products, or for hemodialysis

Первичные конечные точки

• Catheter devices: successful use of the device without removal due to device-related adverse events [Срок оценки: Within 7 days after subject device removal]
• Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location [Срок оценки: Immediately after subject device removal]

Вторичные конечные точки (2)

• Device-related adverse events [Срок оценки: Within 7 days after subject device removal]
• Device-related adverse events within 7 days of device removal [Срок оценки: Within 7 days after subject device removal]

Критерии участия

Критерии включения

• Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.
• Subject is willing and capable of providing informed consent and/or give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.
• Subjects is able to read and understand English or Spanish languages

Критерии исключения

• Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.
• Subject was previously failed screening or was enrolled in this clinical Registry.
• Subject is imprisoned
• Subject is cognitively impaired and unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• Huntsville Hospital — Huntsville
• Loma Linda University Health — Loma Linda
• Tufts Medical Center — Boston

Идентификаторы

NCT: NCT06604039 · 2024-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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