Bayston Multicenter Antimicrobial PD Catheter Safety Study

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients

Conditions
-----------------
End Stage Renal Disease (ESRD)

Intervention / Treatment
-----------------
* Device: PD Catheter group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal disease documented by clinical symptoms and/or laboratory findings Patients scheduled for their first PD catheter implantation Eligible for peritoneal dialysis (CAPD) Willing and able to attend all study follow-up visits Willing and able to understand and sign the informed consent form Exclusion Criteria: A history of allergy to rifampin, trimethoprim or triclosan Use contact lenses or have lens implants Pregnant, lactating or planning to become pregnant during the course of the clinical investigation Recent abdominal surgery, abdominal adhesions, infected abdominal wall, diaphragmatic tears or ileus Respiratory insufficiency Infection: Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening) Febrile viral infection within 4 weeks of entry into the clinical investigation (screening) Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count <2,000/μl Have collagen-vascular, connective tissue, or bleeding disorders Used an investigational medicinal product, biologic or device within the last 30 days prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD catheter group<br>All patients will receive the Bayston PD catheter | Device: PD Catheter group<br>* PD catheter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse events | Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter. | 6 months |