Post-market Clinical Follow-up of Pfmmedical Ports

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-13

Study Completion Date

2023-03-09

Brief Summary

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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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Detailed Description

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Conditions

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Vascular Access Port Patient Satisfaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pfmmedical port implantation

Port implantation for continous vascular access.

pfmmedical implantable vascular access ports

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Jet Port® Plus II Contrast T-Port Contrast T-Port Low Profile Contrast

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No