End Stage Renal Disease (ESRD)BaystonNCT02274896
Bayston Multicenter Antimicrobial PD Catheter Safety Study
A study testing PD Catheter group in people with End Stage Renal Disease (ESRD), run by Medical Components, Inc dba MedComp at 5 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- PD Catheter group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
North Bristol NHS Trust
Bristol
Imperial College London - Hammersmith Hospital
London
Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
Sheffield, S5 7AU
About this study
Official title: A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
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
Read the 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)
- Being tested
- PD Catheter group
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD Catheter groupDevice
PD catheter
| Study group | Role | What they receive |
|---|---|---|
| PD catheter group | Experimental | All patients will receive the Bayston PD catheter Receives: Device: PD Catheter group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Project No Longer in Development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Components, Inc dba MedComp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Wilkie, Dr., Principal investigator, Renal consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274896
- Sponsor's protocol ID
- BAYPDC-14-01
- Acronym
- Bayston
- Status last verified
- Sep 2022
- First submitted
- 17 Oct 2014
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
- ClinicalTrials.gov ID
- NCT02274896
- Acronym / sponsor ID
- Bayston / BAYPDC-14-01
- Conditions
- End Stage Renal Disease (ESRD)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project No Longer in Development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical Components, Inc dba MedCompIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD catheter group | Experimental | Device: PD Catheter groupAll patients will receive the Bayston PD catheter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD Catheter groupPD catheter | Device | PD catheter group |
Primary outcome
Number of Adverse events
Time frame: 6 months
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Wilkie, Dr. principal investigator
Renal consultant
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD Catheter group in people with End Stage Renal Disease (ESRD), run by Medical Components, Inc dba MedComp at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.