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

Not Applicable

Completed

• Conditions: Ileostomy - Stoma

• Registration Number: NCT01957553
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-08-18
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-01
• Last Update Submitted: 2014-09-01
• Results First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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
• 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Preference	21+1 days	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.

Trial Locations

Locations (17)

Imelda Hospital Bonheiden; 🇧🇪 Bonheiden, Belgium

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, Denmark

QPS Netherlands; 🇳🇱 Groningen, Netherlands

Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus; 🇳🇴 Haugesund, Norway

Helse Nordbyen; 🇳🇴 Larvik, Norway

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