Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
3 februari 2017 bijgewerkt door: BBraun Medical SAS
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
31
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Dijon, Frankrijk, 21000
- Centre Georges François Leclerc
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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)
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1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Description of efficacy in term of type of bag deployment and leakage prevention
Tijdsspanne: At least 1 time per day during 14±3 days
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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"
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At least 1 time per day during 14±3 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Peristomal skin evaluation with DET score scale
Tijdsspanne: baseline and 5±3 days and 14±3 days
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baseline and 5±3 days and 14±3 days
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Investigational product bag deployment reason
Tijdsspanne: At each bag change during 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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At each bag change during 14±3 days
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Ease of bag deployment
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of special bag handling
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational product bag ease of use of gas release button
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of control of gas release button
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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General impression about the investigational device before use
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device wearing comfort
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device flexibility
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device discretion
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of base plate handling
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device adhesivity during wear time
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device filter performance with deployed bag
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device filter performance with undeployed bag
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Efficacy of Investigational device gas release button
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Noise during Investigational device wear time
Tijdsspanne: 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
Tijdsspanne: 14±3 days
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14±3 days
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Overall security feeling questionnaire with the Investigational device
Tijdsspanne: 14±3 days
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14±3 days
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Overall satisfaction questionnaire with the Investigational device
Tijdsspanne: 14±3 days
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14±3 days
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Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Tijdsspanne: 14±3 days
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14±3 days
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Overall satisfaction questionnaire with cap cover of the Investigational device
Tijdsspanne: 14±3 days
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14±3 days
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General impression about body image during use of the investigational product
Tijdsspanne: 14±3 days
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(4-points very satisfying to not at all satisfying)
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14±3 days
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Assessment questionnaire of willingness to use and the frequency of use in the future
Tijdsspanne: 14±3 days
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14±3 days
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Assessment of the investigational device wear time
Tijdsspanne: 14±3 days
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14±3 days
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Assessment questionnaire preference between the investigational device and usual appliance
Tijdsspanne: 14±3 days
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14±3 days
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Assessment of use of accessories
Tijdsspanne: At each bag change during 14±3 days
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Choice between some accessories
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At each bag change during 14±3 days
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Assessment of the quality of life with Stoma-QoL questionnaire
Tijdsspanne: At baseline, at 5±3 days and 14±3 days
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At baseline, at 5±3 days and 14±3 days
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Number of participants with Adverse Event as a measure of safety and tolerability
Tijdsspanne: At baseline, at 5±3 days and 14±3 days
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At baseline, at 5±3 days and 14±3 days
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mahaut LECONTE, MD, University Hospital of Paris - Cochin
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2015
Primaire voltooiing (Werkelijk)
1 oktober 2016
Studie voltooiing (Werkelijk)
1 oktober 2016
Studieregistratiedata
Eerst ingediend
4 november 2015
Eerst ingediend dat voldeed aan de QC-criteria
10 november 2015
Eerst geplaatst (Schatting)
11 november 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
6 februari 2017
Laatste update ingediend die voldeed aan QC-criteria
3 februari 2017
Laatst geverifieerd
1 februari 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- OPM-G-H-1401
- 2015-A00611-48 (Andere identificatie: FRENCH HEALTH AUTORITY)
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