- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01800916
Safety and Performance of New 1-piece Ostomy Product
Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Humlebæk, Danmark, 3050
- Holtedam 3
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Have given written informed consent and signed letter of authority form.
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the bags themselves.
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Currently use a 1-piece flat ostomy appliance with open bag.
- Use minimum 1 ostomy appliance every second day.
- Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
- Must be able to use a custom cut ostomy appliance.
- Accept to test three 1-piece ostomy appliances in the investigation.
- Negative result of a pregnancy test for women of childbearing age (only DK).
Exclusion Criteria:
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
- Currently using ostomy belt.
- Currently using extended wear product.
- Known hypersensitivity towards any of the test products
- Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment sequence 1
The subjects randomised to Treatment sequence 1 are going to test
The subjects test the three test products in a randomised order: ABS; BSA; SAB |
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
|
Eksperimentell: Treatment sequence 2
The subjects randomised to Treatment sequence 2 are going to test
The subjects test the three test products in a randomised order: CBS; BSC; SCB |
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
|
Eksperimentell: Treatment sequence 3
The subjects randomised to Treatment sequence 3 are going to test
The subjects test the three test products in a randomised order: ACS; CSA; SAC |
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Degree of Leakage
Tidsramme: one week
|
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices:
|
one week
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Birte Jakobsen, Dr., Coloplast A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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