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

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

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BBraun Medical SAS

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2015

Primær fullføring (Faktiske)

1. oktober 2016

Studiet fullført (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først innsendt

4. november 2015

Først innsendt som oppfylte QC-kriteriene

10. november 2015

Først lagt ut (Anslag)

11. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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