Bayston Multicenter Antimicrobial PD Catheter Safety Study

Medcomp

Status

Withdrawn

Conditions

End Stage Renal Disease (ESRD)

Treatments

Device: PD Catheter group

Study type

Interventional

Funder types

Industry

Identifiers

NCT02274896

BAYPDC-14-01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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