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 Withdrawn at 5 sites in 3 countries.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
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
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
Browse Kidney Failure, Chronic studies →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.
Exclusion Criteria:
Infection:
All patients will receive the Bayston PD catheter
Device: PD Catheter group
PD catheter
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
This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical Components, Inc dba MedComp