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

3 februari 2017 uppdaterad av: BBraun Medical SAS
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

31

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Dijon, Frankrike, 21000
        • Centre Georges François Leclerc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Enhet: AOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Description of efficacy in term of type of bag deployment and leakage prevention
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peristomal skin evaluation with DET score scale
Tidsram: baseline and 5±3 days and 14±3 days
baseline and 5±3 days and 14±3 days
Investigational product bag deployment reason
Tidsram: 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
Tidsram: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Ease of special bag handling
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device wearing comfort
Tidsram: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device flexibility
Tidsram: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Investigational device discretion
Tidsram: 14±3 days
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
14±3 days
Ease of base plate handling
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 14±3 days
14±3 days
Overall security feeling questionnaire with the Investigational device
Tidsram: 14±3 days
14±3 days
Overall satisfaction questionnaire with the Investigational device
Tidsram: 14±3 days
14±3 days
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Tidsram: 14±3 days
14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device
Tidsram: 14±3 days
14±3 days
General impression about body image during use of the investigational product
Tidsram: 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
Tidsram: 14±3 days
14±3 days
Assessment of the investigational device wear time
Tidsram: 14±3 days
14±3 days
Assessment questionnaire preference between the investigational device and usual appliance
Tidsram: 14±3 days
14±3 days
Assessment of use of accessories
Tidsram: 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
Tidsram: 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
Tidsram: At baseline, at 5±3 days and 14±3 days
At baseline, at 5±3 days and 14±3 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

BBraun Medical SAS

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2015

Primärt slutförande (Faktisk)

1 oktober 2016

Avslutad studie (Faktisk)

1 oktober 2016

Studieregistreringsdatum

Först inskickad

4 november 2015

Först inskickad som uppfyllde QC-kriterierna

10 november 2015

Första postat (Uppskatta)

11 november 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 februari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 februari 2017

Senast verifierad

1 februari 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • OPM-G-H-1401
  • 2015-A00611-48 (Annan identifierare: FRENCH HEALTH AUTORITY)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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