An observational study in Vascular Access Port and Patient Satisfaction, sponsored by pfm medical gmbh. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by pfm medical gmbh · Observational
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 focus is on patient reported satisfaction, clinical application, and complication rates.
pfm medical gmbh is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
150 patients requiring repeated vascular access
Exclusion Criteria:
Port implantation for continous vascular access.
Device: pfmmedical implantable vascular access ports
Implantion of an implantable vascular access port which facilitates repeated vascular access intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products and blood sampling using a Huber needle.
Also known as: Jet Port® Plus II Contrast, T-Port Contrast, T-Port Low Profile Contrast
Patients satisfaction
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 (6 months after implantation). The following 4 domains of the validated questionnaire by Nagel et.al., 2012 are considered as relevant for the clinical outcome: * Overall, how satisfied are you with the port system? * In a similar situation, would you choose the port again? * How satisfied are you with the cosmetic result? * Does the port cause pain?
Time frame: 6 months after port implantation
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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