Bayston Multicenter Antimicrobial PD Catheter Safety Study

End Stage Renal Disease (ESRD) Clinical Trial

— Bayston  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02274896
• Other study ID #: BAYPDC-14-01
• Status: Withdrawn
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2022
• Source: Medical Components, Inc dba MedComp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic

Intervention

Device:
• PD Catheter group
PD catheter

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Netherlands	University Medical Center Utrecht	Utrecht
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Medical Components, Inc dba MedComp

Countries where clinical trial is conducted

Belgium,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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