Post-market Clinical Follow-up of Pfmmedical Ports

pfm medical

Status: Completed

Conditions: Patient Satisfaction; Vascular Access Port

Treatments: Device: pfmmedical implantable vascular access ports

Study type: Observational

Funder types: Industry

Identifiers

NCT05209828

PMCF study pfmmedical Ports

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

149 participants in 1 patient group

pfmmedical port implantation

Description:

Port implantation for continous vascular access.

Treatment:

Device: pfmmedical implantable vascular access ports