Post-market Clinical Follow-up of Pfmmedical Ports

NCT05209828 | Completed DMC FDA Device

• 1 other identifier: PMCF study pfmmedical Ports
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Port; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

pfmmedical port implantation

Port implantation for continous vascular access.

Device: pfmmedical implantable vascular access ports

Interventions

pfmmedical implantable vascular access ports 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.

Also known as: Jet Port® Plus II Contrast, T-Port Contrast, T-Port Low Profile Contrast

pfmmedical port implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

150 patients requiring repeated vascular access

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• pfm medical gmbh: lead

Study Sites (1)

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related 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.

  PMID: 21851433 BACKGROUND

Related Links

• manufacturer homepage of the investigational devices

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Phillip Knebel, Prof. Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: April 13, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: April 5, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)