Vascular Access PortNCT05209828
Post-market Clinical Follow-up of Pfmmedical Ports
An observational study of Vascular Access Port and Patient Satisfaction, run by pfm medical gmbh at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Port, Patient Satisfaction
- What is being tested?
- pfmmedical implantable vascular access ports
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 149 participants
- Where
- 1 siteGermany
- Study dates
- 13 Apr 2022to 9 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients requiring repeated vascular access
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
- Conditions
- Vascular Access Port, Patient Satisfaction
- Being tested
- pfmmedical implantable vascular access ports
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pfmmedical implantable vascular access portsDevice
Also called Jet Port® Plus II Contrast, T-Port Contrast, T-Port Low Profile Contrast
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.
| Study group | Role | What they receive |
|---|---|---|
| pfmmedical port implantation | Port implantation for continous vascular access. Receives: Device: pfmmedical implantable vascular access ports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months after port implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start13 Apr 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access PortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Knebel, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209828
- Sponsor's protocol ID
- PMCF study pfmmedical Ports
- Status last verified
- Nov 2023
- First submitted
- 13 Jan 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21851433
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports
- ClinicalTrials.gov ID
- NCT05209828
- Acronym / sponsor ID
- PMCF study pfmmedical Ports
- Conditions
- Vascular Access Port, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pfmmedical port implantation | – | Device: pfmmedical implantable vascular access portsPort implantation for continous vascular access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients requiring repeated vascular access
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pfmmedical implantable vascular access portsAlso: Jet Port® Plus II Contrast, T-Port Contrast, T-Port Low Profile ContrastImplantion 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. | Device | pfmmedical port implantation |
Primary outcome
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 21851433Nagel 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.
- manufacturer homepage of the investigational devicesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Knebel, Prof. Dr. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Port and Patient Satisfaction, run by pfm medical gmbh at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients satisfaction (time frame: 6 months after port implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.