Post-market Clinical Follow-up of Pfmmedical Ports

Completed

• Conditions: Vascular Access Port; Patient Satisfaction
• Interventions: Device: pfmmedical implantable vascular access ports

• Registration Number: NCT05209828
• Lead Sponsor: pfm medical gmbh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Study Start: 2022-04-13
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pfmmedical port implantation	pfmmedical implantable vascular access ports	Port implantation for continous vascular access.

Primary Outcome Measures

Name	Time	Method
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?

Trial Locations

Locations (1)

Heidelberg University Hospital; 🇩🇪 Heidelberg, Baden-Württemberg, Germany