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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01957553
Other study ID # CP243
Secondary ID
Status Completed
Phase N/A
First received October 1, 2013
Last updated September 1, 2014
Start date September 2013
Est. completion date December 2013

Study information

Verified date September 2014
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial Summary

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product


Description:

The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 1.Have given written informed consent and letter of authority (DK only)

- 2.Be at least 18 years of age and have full legal capacity.

- 3.Be able to handle the products her/himself

- 4.Have an ileostomy with a diameter between 10 and 40 mm.

- 5.Have had their ostomy for at least three months.

- 6.Be willing to use minimum 2 base plates every week

- 7.Currently use 2-piece flat mechanical coupling product with open bag 8

- 11.Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

- 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.

- 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

- 3.Is pregnant or breastfeeding.

- 4.Is participating in other interventional clinical investigations or have previously participated in this investigation

- 5.Has participated in the previous explorative study CP234

- 6.

- 7.Known hypersensitivity towards any of the test products

- 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S

Locations

Country Name City State
Belgium Imelda Hospital Bonheiden Bonheiden
Denmark Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland Aabenraa
Denmark Coloplast A/S Humlebæk
Denmark Stomiambulatoriet, Kolding Sygehus Kolding
Denmark Stomiambulatoriet A5, Odense Hospital Odense C
Denmark Kirurgisk ambulatorium/Stomiambulatoriet OUH Svenborg
Denmark Vejle Sygehus, Stomiambulatoriet B120 Vejle
Netherlands QPS Netherlands Groningen
Norway Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus Haugesund
Norway Helse Nordbyen Larvik
Sweden Länssjukhhuset gävle, Stomimottagningen Gävle
Sweden Kirug kliniken Centralsjukhuset Karlstad
Sweden Kirurgens Mottagning Malmö
Sweden Capio St. Görans Sjukhus AB, kirurgkliniken Stockholm
Sweden karolinska Universitetssjukhuset Solna Stomimottagningen Stockholm
Sweden Södersjukhuset Stockholm
Sweden Stomimottagningen Centrllasarette i Västerås Västerås

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Belgium,  Denmark,  Netherlands,  Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preference The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. 21+1 days No
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