Post-market Clinical Follow-up of Pfmmedical Ports

Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05209828

Enrollment

149

Registered

2022-01-27

Start date

2022-04-13

Completion date

2023-03-09

Last updated

2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction, Vascular Access Port

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 focus is on patient reported satisfaction, clinical application, and complication rates.

Interventions

DEVICEpfmmedical 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Patients satisfaction	6 months after port implantation	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?

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026