Post-market Clinical Follow-up of Pfmmedical Ports

April 4, 2024 updated by: pfm medical gmbh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Heidelberg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

150 patients requiring repeated vascular access

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pfmmedical port implantation
Port implantation for continous vascular access.
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.
Other Names:
  • Jet Port® Plus II Contrast
  • T-Port Contrast
  • T-Port Low Profile Contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients satisfaction
Time Frame: 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?
6 months after port implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pfm medical gmbh

Investigators

  • Principal Investigator: Phillip Knebel, Prof. Dr., University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PMCF study pfmmedical Ports

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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