Post-market Clinical Follow-up of Pfmmedical Ports

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.

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Key information

Conditions

Vascular Access Port Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pfmmedical implantable vascular access ports

Device

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.

Other names: Jet Port® Plus II Contrast, T-Port Contrast, T-Port Low Profile Contrast

Primary outcomes

Patients satisfaction

Time frame: 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?

Sponsors and collaborators

Lead sponsor

pfm medical gmbh

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 27, 2022
Registry last updated: Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed