Back to resultsBayston Multicenter Antimicrobial PD Catheter Safety Study (Bayston)
Primary Purpose
End Stage Renal Disease (ESRD)
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PD Catheter group
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease (ESRD)
Eligibility Criteria
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
Sites / Locations
- UZ Leuven
- University Medical Center Utrecht
- North Bristol NHS Trust
- Imperial College London - Hammersmith Hospital
- Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD catheter group
Arm Description
All patients will receive the Bayston PD catheter
Outcomes
Primary Outcome Measures
Number of Adverse events
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
Secondary Outcome Measures
Full Information
NCT ID
NCT02274896
First Posted
October 17, 2014
Last Updated
September 13, 2022
Sponsor
Medical Components, Inc dba MedComp
1. Study Identification
Unique Protocol Identification Number
NCT02274896
Brief Title
Bayston Multicenter Antimicrobial PD Catheter Safety Study
Acronym
Bayston
Official Title
A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Project No Longer in Development
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Components, Inc dba MedComp
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD catheter group
Arm Type
Experimental
Arm Description
All patients will receive the Bayston PD catheter
Intervention Type
Device
Intervention Name(s)
PD Catheter group
Intervention Description
PD catheter
Primary Outcome Measure Information:
Title
Number of Adverse events
Description
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wilkie, Dr.
Organizational Affiliation
Renal consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Imperial College London - Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Bayston Multicenter Antimicrobial PD Catheter Safety Study
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