End Stage Renal Disease (ESRD)
Conditions
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.
Interventions
DEVICEPD Catheter group
PD catheter
Sponsors
Medical Components, Inc dba MedComp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse events | 6 months | Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter. |
Countries
Belgium, Netherlands, United Kingdom
Outcome results
None listed