Status:
COMPLETED
Post-market Clinical Follow-up of Pfmmedical Ports
Lead Sponsor:
pfm medical gmbh
Conditions:
Vascular Access Port
Patient Satisfaction
Eligibility:
All Genders
18+ years
Brief Summary
Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT05209828
Start Date
April 13 2022
End Date
March 9 2023
Last Update
April 5 2024
Active Locations (1)
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1
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, Germany, 69120