Bayston Multicenter Antimicrobial PD Catheter Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD catheter group

All patients will receive the Bayston PD catheter

Group Type EXPERIMENTAL

PD Catheter group

Intervention Type DEVICE

PD catheter

Interventions

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PD Catheter group

PD catheter

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No