Post-market Clinical Follow-up of Pfmmedical Ports

N/ACompletedNCT05209828

pfm medical gmbh149 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Vascular Access Port Patient Satisfaction

Interventions

pfmmedical implantable vascular access portsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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