Prospective, monocentric observational study on the clinical use and patient satisfaction of pfmmedical implantable vascular access ports
- Conditions
- Z95.81
- Registration Number
- DRKS00026150
- Lead Sponsor
- pfm medical ag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 150
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
• 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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method