The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials
The objective of this clinical investigation is to establish the safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD patients initiating CAPD. The Bayston catheter is not expected to cause any safety related complications or reactions other than those described for not-impregnated peritoneal dialysis catheters. Thus the objective of this clinical investigation is to evaluate whether the Bayston catheter causes any unanticipated serious adverse device effects (USADE). The primary hypothesis for this study is that the Bayston Antimicrobial Peritoneal Dialysis Catheter is a safe catheter for peritoneal dialysis. No claims regarding efficacy will be verified during this clinical investigation. This is a prospective, non-randomized, single-arm, multi-center study involving patients suffering from end stage renal disease who are eligible for treatment with peritoneal dialysis. Forty-three (43) patients will be enrolled who will be followed up to 6 months after implantation of the Bayston Antimicrobial Peritoneal Dialysis Catheter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
PD catheter
UZ Leuven
Leuven, Belgium
University Medical Center Utrecht
Utrecht, Netherlands
North Bristol NHS Trust
Bristol, United Kingdom
Imperial College London - Hammersmith Hospital
London, United Kingdom
Number of Adverse events
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
Sheffield, United Kingdom