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WithdrawnNCT02274896BaystonUpdated Sep 15, 2022

Bayston Multicenter Antimicrobial PD Catheter Safety Study

An interventional study of PD Catheter group in End Stage Renal Disease (ESRD), sponsored by Medical Components, Inc dba MedComp. Withdrawn at 5 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Medical Components, Inc dba MedComp · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Project No Longer in Development
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • End Stage Renal Disease (ESRD)
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Medical Components, Inc dba MedComp is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    PD catheter group

    All patients will receive the Bayston PD catheter

    Device: PD Catheter group

Interventions

  • DevicePD Catheter group

    PD catheter

06

What researchers measure

Primary outcomes

  1. Number of Adverse events

    Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.

    Time frame: 6 months

07

Study locations

5 sites
  • UZ Leuven
    Leuven, Belgium
  • University Medical Center Utrecht
    Utrecht, Netherlands
  • North Bristol NHS Trust
    Bristol, United Kingdom
  • Imperial College London - Hammersmith Hospital
    London, United Kingdom
  • Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
    Sheffield, S5 7AU, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02274896
Lead sponsor
Medical Components, Inc dba MedComp
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Nov 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Sep 15, 2022

Study contacts

Martin Wilkie, Dr.
principal investigator · Renal consultant

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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