Post-market Clinical Follow-up of Pfmmedical Ports

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209828
• Other study ID #: PMCF study pfmmedical Ports
• Status: Completed
• Start date: April 13, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: November 2023
• Source: pfm medical gmbh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Device:
• pfmmedical 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.

Locations

Country	Name	City	State
Germany	Heidelberg University Hospital	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
pfm medical gmbh

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Nagel SN, Teichgraber UK, Kausche S, Lehmann A. Satisfaction and quality of life: a survey-based assessment in patients with a totally implantable venous port system. Eur J Cancer Care (Engl). 2012 Mar;21(2):197-204. doi: 10.1111/j.1365-2354.2011.01275.x. Epub 2011 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	6 months after port implantation

External Links

•   manufacturer homepage of the investigational devices