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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pfmmedical port implantation | Port implantation for continous vascular access. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 6 months after port implantation |
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Inclusion Criteria:
Exclusion Criteria:
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150 patients requiring repeated vascular access
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Knebel, Prof. Dr. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg University Hospital | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21851433 | Background | 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. |
| Label | URL |
|---|---|
| manufacturer homepage of the investigational devices | View source |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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