CompletedNot Applicable

Post-market Clinical Follow-up of Pfmmedical Ports

Germany149 participantsStarted 2022-04-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patients satisfaction

Timeframe: 6 months after port implantation

Trial details

NCT IDNCT05209828

Sponsorpfm medical gmbh

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-09

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