Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

Ileostomy - Stoma Clinical Trial

Official title:

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957553
• Other study ID #: CP243
• 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

• Ileostomy - Stoma

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