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Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

3. februar 2017 opdateret af: BBraun Medical SAS
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Dijon, Frankrig, 21000
        • Centre Georges Francois Leclerc

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is at least 18 years old
  • Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
  • Patient having a colostomy for at least 1 month
  • Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
  • Patient having a stoma protusion smaller than or equal to 1.5 cm
  • Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
  • Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
  • Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
  • Patient covered by social security

Exclusion Criteria:

  • Patient experiencing repeated leakages with the usual pouching system
  • Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
  • Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
  • Patient already participating in another clinical study or who have previously participated in this investigation
  • Pregnant or breast-feeding woman

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AOS-C2000-B
A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
Enhed: AOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Description of efficacy in term of type of bag deployment and leakage prevention
Tidsramme: At least 1 time per day during 14±3 days
After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
At least 1 time per day during 14±3 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peristomal skin evaluation with DET score scale
Tidsramme: baseline and 5±3 days and 14±3 days
baseline and 5±3 days and 14±3 days
Investigational product bag deployment reason
Tidsramme: At each bag change during 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
At each bag change during 14±3 days
Ease of bag deployment
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Ease of special bag handling
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational product bag ease of use of gas release button
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Ease of control of gas release button
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
General impression about the investigational device before use
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device wearing comfort
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device flexibility
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device discretion
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Ease of base plate handling
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device adhesivity during wear time
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device filter performance with deployed bag
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device filter performance with undeployed bag
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Efficacy of Investigational device gas release button
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Noise during Investigational device wear time
Tidsramme: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
Tidsramme: 14±3 days
14±3 days
Overall security feeling questionnaire with the Investigational device
Tidsramme: 14±3 days
14±3 days
Overall satisfaction questionnaire with the Investigational device
Tidsramme: 14±3 days
14±3 days
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Tidsramme: 14±3 days
14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device
Tidsramme: 14±3 days
14±3 days
General impression about body image during use of the investigational product
Tidsramme: 14±3 days
(4-points very satisfying to not at all satisfying)
14±3 days
Assessment questionnaire of willingness to use and the frequency of use in the future
Tidsramme: 14±3 days
14±3 days
Assessment of the investigational device wear time
Tidsramme: 14±3 days
14±3 days
Assessment questionnaire preference between the investigational device and usual appliance
Tidsramme: 14±3 days
14±3 days
Assessment of use of accessories
Tidsramme: At each bag change during 14±3 days
Choice between some accessories
At each bag change during 14±3 days
Assessment of the quality of life with Stoma-QoL questionnaire
Tidsramme: At baseline, at 5±3 days and 14±3 days
At baseline, at 5±3 days and 14±3 days
Number of participants with Adverse Event as a measure of safety and tolerability
Tidsramme: At baseline, at 5±3 days and 14±3 days
At baseline, at 5±3 days and 14±3 days

Samarbejdspartnere og efterforskere

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

Sponsor

BBraun Medical SAS

Efterforskere

  • Ledende efterforsker: Mahaut LECONTE, MD, University Hospital of Paris - Cochin

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. november 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

4. november 2015

Først indsendt, der opfyldte QC-kriterier

10. november 2015

Først opslået (Skøn)

11. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • OPM-G-H-1401
  • 2015-A00611-48 (Anden identifikator: FRENCH HEALTH AUTORITY)

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 AOS-C2000-B

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