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Safety and Performance of a New Coating for Urinary Intermittent Catheters

26. august 2020 opdateret af: Coloplast A/S

Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • Department of Urology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  1. Have given written informed consent and signed letter of authority
  2. Be at least 18 years of age and have full legal capacity
  3. Be a male
  4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits

Exclusion Criteria:

  1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
  2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
  3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
  4. Known hypersensitivity toward any of the test products -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eksperimentel: Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eksperimentel: Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eksperimentel: Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eksperimentel: Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eksperimentel: Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
Enhed: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Enhed: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Discomfort During Catheterization
Tidsramme: 1 day
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Coloplast A/S

Efterforskere

  • Ledende efterforsker: Per Bagi, MD, PhD, Department of Urology, Rigshospitalet Denmark

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

22. februar 2013

Først indsendt, der opfyldte QC-kriterier

26. februar 2013

Først opslået (Skøn)

28. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CP235 (Anden identifikator: Coloplast)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Intermitterende urethral kateterisation

Kliniske forsøg med ZN-D catheter

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner