Bayston BAYPDC-14-01
Research type
Research Study
Full title
A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD patients
IRAS ID
165678
Contact name
Philip Sax
Contact email
Sponsor organisation
Medical Components, Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a prospective, non-randomized, single-arm, multi-center study to investigate the safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter involving patients suffering from end stage renal disease (ESRD) who are eligible for treatment with peritoneal dialysis.
The device under investigation is the Bayston Antimicrobial Peritoneal Dialysis Catheter which is impregnated with rifampin, trimethoprim and triclosan which provides long-term antimicrobial activity.
Forty-three patients will be enrolled at five hospitals in the Netherlands, Belgium and UK.
Enrolled patients will be followed up to 6 months after implantation of the Bayston catheter. The study involves a screening visit, a surgery visit, an examination at the day of discharge and 3 follow-up visits. Details are as follows:
Visit 1: Screening visit; patients will be asked about their general state of health and prior medical history. A general physical examination will be performed; blood pressure, heart rate and temperature. Blood samples will be taken as part of the standard procedure for dialysis patients in order to get a general view of the patient’s health.
Visit 2: Operation: During the operation, the Bayston catheter will be implanted in the abdomen and an exit site will be created in the abdomen or chest. The surgical procedure for the Bayston catheter is not different from peritoneal dialysis catheters that are not soaked with antimicrobials and it does not require more time.
Day of discharge and visits at 1, 3 and 6 months after surgery: At each visit, a physical examination will be performed focusing on the abdomen, the catheter and the wound around the catheter. Patients will be asked if they experienced any side effects and if there was a change in medication since last visit. Blood pressure, heart rate and temperature will be measured. Blood samples will be taken.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1276
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion