Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
OBJECTIVES: Primary * To compare the rate of port failure, defined as the occurrence of port malfunction or port infection within 12 months after port insertion, in patients with cancer requiring long-term adjuvant intravenous chemotherapy undergoing insertion of a newly designed, FDA-approved Vortex® implantable vascular access port vs a conventional vascular access port. Secondary * To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion. * To compare the rate of central vein thrombosis at 6 and 12 months after port insertion. * To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion. * To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion. * To compare the death from all causes. * To compare the incidence of port-related interventions at 6 and 12 months after port insertion. OUTLINE: Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients undergo insertion of a conventional vascular access port. Patients then receive standard chemotherapy. * Arm II : Patients undergo insertion of the Vortex® implantable vascular access port. Patients then receive standard chemotherapy. All episodes of access to the port are documented for 12 months after port insertion. Information including the reason for port access and difficulty in access is collected. Complications, such as occlusion and infection, implant duration, and incidence of port-related interventions are assessed at 6 and 12 months after port insertion.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
