Bayston Multicenter Antimicrobial PD Catheter Safety Study

Not Applicable

Withdrawn

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Device: PD Catheter group

• Registration Number: NCT02274896
• Lead Sponsor: Medical Components, Inc dba MedComp

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.

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2014-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD catheter group	PD Catheter group	All patients will receive the Bayston PD catheter

Primary Outcome Measures

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

Trial Locations

Locations (5)

UZ Leuven; 🇧🇪 Leuven, Belgium

Imperial College London - Hammersmith Hospital; 🇬🇧 London, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands