NCT02274896

Bayston Multicenter Antimicrobial PD Catheter Safety Study

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical Components, Inc dba MedComp · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DEVICE	PD Catheter group	PD catheter

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-10-24
• Last updated: 2022-09-15

Locations

5 sites across 3 countries: Belgium, Netherlands, United Kingdom