Bayston Multicenter Antimicrobial PD Catheter Safety Study (Bayston)

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

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

Study Overview

• Status: Withdrawn
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Device: PD Catheter group

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven
• Netherlands
  • Utrecht, Netherlands
    • University Medical Center Utrecht
• United Kingdom
  • Bristol, United Kingdom
    • North Bristol NHS Trust
  • London, United Kingdom
    • Imperial College London - Hammersmith Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD catheter group; All patients will receive the Bayston PD catheter	Device: PD Catheter group; PD catheter

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

Collaborators and Investigators

• Sponsor: Medical Components, Inc dba MedComp
• Investigators: Principal Investigator: Martin Wilkie, Dr., Renal consultant

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: BAYPDC-14-01