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Post-market Clinical Follow-up of Pfmmedical Ports

Sponsor
pfm medical ag (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05209828
Collaborator
(none)
150
Enrollment
1
Location
9.7
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: pfmmedical implantable vascular access ports

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports
Actual Study Start Date :
Apr 13, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heidelberg University Hospital Heidelberg Baden-Württemberg Germany 69120

    Sponsors and Collaborators

    • pfm medical ag

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    pfm medical ag
    ClinicalTrials.gov Identifier:
    NCT05209828
    Other Study ID Numbers:
    • PMCF study pfmmedical Ports
    First Posted:
    Jan 27, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Aug 17, 2022