Z95.81
Conditions
Interventions
Group 1: Patients with a medical indication for port implantation
Sponsors
pfm medical gmbh
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age: = 18 years • Medical indication for port catheter implantation. • The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study. • Patient information has been provided and written consent exists.
Exclusion criteria
Exclusion criteria: • Contraindications according to the manufacturer´s instructions for use (IFU). • The patient is institutionalised by court or official order (MPDG §27). • Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study. • Patients who currently already have a port implanted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study hypothesis is that the patients’ satisfaction after the study intervention is not worse than the satisfaction identified in the current literature. Satisfaction is determined using the patient questionnaire (six months after implantation). | — |
Countries
Germany
Contacts
Public ContactKai Braunsteffer
pfm medical ag
Outcome results
None listed