- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02274896
Bayston Multicenter Antimicrobial PD Catheter Safety Study (Bayston)
A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Leuven, Belgien
- UZ Leuven
-
-
-
-
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Bristol, Det Forenede Kongerige
- North Bristol NHS Trust
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London, Det Forenede Kongerige
- Imperial College London - Hammersmith Hospital
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Sheffield, Det Forenede Kongerige, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
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-
-
-
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Utrecht, Holland
- University Medical Center Utrecht
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PD catheter group
All patients will receive the Bayston PD catheter
|
PD catheter
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Adverse events
Tidsramme: 6 months
|
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
|
6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Martin Wilkie, Dr., Renal consultant
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BAYPDC-14-01
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