Clinical Research Directory

Efficacy and Safety of FLEXIPORT Implantable Port in Chemotherapeutic Treatments

Sponsor: Portal Access Ltd.

Summary

The goal of this clinical trial is to assess, in a clinical setting, the efficacy and the safety of FLEXIPORT, a totally implantable venous access device (TIVAD) designed to provide a repeated access to the vascular system, in patients with malignant diseases requiring central venous access for administration of chemotherapeutic treatments. The main question it aims to answer is what is the success rate of the device in providing vascular access, with the success rate defined as proportion of participants with a functioning device at 180 days post-implantation or at the time of removal, if the latter occurred for reasons other than adverse event or device deficiency.

Official title: A Single-arm Study Evaluating the Efficacy and Safety of FLEXIPORT, a Single-incision Totally Implantable Venous Access Device, in Patients Receiving Chemotherapeutic Treatments

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